R & D Manager-medical technology company

My client is a leading medical technology company that is growing. They will consider out of state candidates. This position is located in the Gainesville, FL area.

The R&D Manager will lead important tasks and projects in new product development (NPD) and sustaining engineering including concept and prototype development, design, verification and validation, process development and transfer to manufacturing of tissue and biologic products and medical devices. This position will supervise project leaders and also lead cross-functional teams to develop new products, processes and process improvements according to our Strategic Plan in compliance with all appropriate regulations and guidelines. He/she will also be responsible for managing activities in our R&D Lab including supervising scientists and technicians and expanding laboratory capabilities.

Responsibilities include technology assessment; product/process development, validation and implementation; supply chain development and troubleshooting in support of manufacturing.

This position is responsible for supporting, developing, and protecting company intellectual property, and assessing and remaining current with new developments and industry trends.

Educational Requirements / Qualifications

  • Bachelor’s Degree in Engineering or related discipline (Graduate degree preferred)
  • Solid experience in tissue engineering and regenerative medicine products (cleanroom processing, aseptic technique, tissue preservation, AATB standards)
  • Minimum of five (5) years’ experience in leading cross functional teams in Product Development
  • Experience managing engineers and scientists as direct reports
  • Demonstrated hands-on technical skill in planning and execution of product verification and validation and process validations and product/process transfer to manufacturing.
  • Ability to work independently, lead in a collaborative team environment and influence leadership team and key stakeholders
  • Strong interpersonal skills, mentorship skills, and time-management skills
  • Working knowledge of requirements and regulatory approval process for Class II and Class III medical devices, biologics and tissue (HCT/P 361) products
  • Experience in process troubleshooting and/or continuous improvement a plus
  • Prior experience developing surgical instrumentation and/or electrical stimulation devices a plus

Primary Responsibilities: The specific duties of the Project Engineer/Engineering Manger include but are not limited to:

  • Manage multiple project teams of R&D engineers and scientists and extended team (QA, Regulatory Affairs, Marketing) to develop multiple NPD projects from development through product launch
  • Supervise senior engineers, scientists and project leaders in project activities to ensure on target, on time launch of new products according to AxoGen Strategic Plan
  • Develop NPD project plans including Verification & Validation (V&V) plans, MS Project timelines, budgets and resource requirements.
  • Direct cross-functional team in conducting hazard analysis (e.g., FTA, FMECA)
  • Interface with Marketing/Sales, physician end users, and hospitals to understand customer requirements and critical product features. Gather, develop and document medical product specifications; identify competitive products/procedures; assist with product positioning decisions.
  • Support and guide RA & QA with regulatory submissions.
  • Manage projects via transparent, data-driven approach using metrics, dashboards and regular project (Stage-Gate) reviews and technical design reviews.
  • Support the development and protection of company Intellectual Property through new invention disclosures, identification of potential licensing opportunities, and technical assistance with ongoing patent prosecution.
  • Assess external technology and remain current with new development and industry trends, including ongoing investigation and evaluation of related research, products, and technology licensing opportunities. Research and obtain intelligence on competitors’ products and processes.
  • Support the development of departmental strategic direction, business processes and project execution strategies.
  • Contribute to recruiting and developing junior engineers and scientists, technicians, co-ops and interns.

If interested and more importantly qualified, please send updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately.

This position can pay a very competitive base salary plus bonus and excellent comprehensive benefits package.

Unfortunately, Visa sponsorship or transfer not available for this role.

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Sr. Software Engineer-C++/Qt – Medical Device start up

My client is a growing fast-paced medical device start-up based out of Bedford, MA.

This is an exciting opportunity to join a small and nimble software development team, working on the development and commercialization of state-of-the-art medical imaging devices. We are seeking a talented and creative engineer who wants to make a bigger impact on society through healthcare. If you join our team, you will work alongside experts in multiple scientific and engineering disciplines to design, develop, and commercialize systems software for our imaging platform. The qualified candidate will collaborate with a cross-functional team, including marketing, to define and implement various feature enhancements to our medical imaging platform. This role will also be responsible for contributing to all aspects of software and user interface development for new products, working closely with hardware designers and systems engineers to develop novel medical imaging systems.

Position Requirements:

  • 7+ years of relevant system level software design, development, and software/hardware integration experience. Experience with image acquisition, processing, and display is a plus.
  • Proficient with C++. Experience with Qt based cross-platform software development is preferred.
  • Proficient in multi-threaded programming
  • Proficient with object oriented design and programming
  • Familiarity with both Linux and Windows operating systems
  • Expert software debugging and problem solving skills
  • Experience with HTML5, Javascript, and CSS is a plus
  • Ability to learn new technologies and how to leverage them to achieve development

objectives and solve design problems

  • Must be able to identify and resolve problems and requests in a proactive and timely manner
  • Must be able to gather, analyze and exchange information skillfully
  • Self-starter with the desire and ability to take initiative on projects
  • Proven ability to work as a part of a multi-functional organization
  • Effective written and verbal communication skills as well as presentation skills
  • Willingness to interact and support our field personnel as required
  • Strong fit with our Core Values
  • Minimal travel as necessary

Education Requirements:

  • A minimum of a Bachelor’s Degree required in Computer Science, Software, Electrical, Biomedical or Computer Engineering.

If interested and more importantly qualified, please send updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately.

This position can pay a very competitive base salary plus bonus and excellent comprehensive benefits package.


Systems Administrator

My client is a highly successful global medical technology company and growing. They are located NW of Boston, MA. You would join a small team as the senior resource reporting to the IT Director and wear many hats. They are looking for a local candidate and you must be able to work in the USA without restrictions.

In this role, you will be responsible for the design, implementation, troubleshooting and maintenance of all Information Technology systems. Manage the IT system infrastructure and any processes related to these systems. Provide support to IT systems including day-to-day operations, monitoring and problem resolution for all of the client/server/storage/network/VoIP and mobile devices, etc. This includes installing, diagnosing, repairing, maintaining, and upgrading all hardware and software to ensure maximum availability and optimal computing and equipment performance. This position will also be responsible for proposing and implementing system and process enhancements that will improve the performance and reliability of the system.

There may be occasional travel required .

Specific Responsibilities:

  • Install, maintain and support wide-area and local area network hardware, software, and telecommunications services such as servers, system software, software applications, routers, switches, access-points, VoIP, modems, and cabling.
  • Establish and maintain network user accounts, user environment, directories, and security.
  • Provide L2/L3 support to end-users. Respond to the needs and questions of network users concerning their access to resources on the network and the operation of various software programs.
  • Assist in the development and management of policies and procedures related to network hardware and software acquisition, use, support, security, backup and disaster recovery.
  • Communicate standards for use, operations, and security of network, personal computers, and data.
  • Communicate with other departments to report and resolve software, hardware, and operations problems.
  • Collect and analyze network and server utilization and security.
  • Work with Internet Service Providers and various hardware/software vendors to manage and troubleshoot server, network or application issues.
  • Keep abreast of emerging Infrastructure/Systems technologies and trends and identify opportunities to leverage them to drive innovation and ensure security.
  • Available on-call and after hours to monitor and respond to alerts, working with users and management to coordinate downtime for scheduled maintenance
  • Manage daily and yearly infrastructure projects as assigned.
  • Contribute to the infrastructure operation and strategic planning.
  • Provide high quality customer service throughout every interaction.
  • Participate in special projects and other duties as assigned

Experience, Knowledge, and Skills Required:

A successful candidate will demonstrate an ability to plan ahead, organize ideas, focus on quality, communicate clearly, solve problems methodically, and pay close attention to detail. The following knowledge and/or experience are also required:

  • Bachelor’s degree (B.A./B.S.) or higher in information technology or related field
  • Minimum 3-5 years of IT Systems Administration experience, preferably in publicly traded, medical device or pharmaceutical companies. Evidence of innovative thinking and high energy is required.
  • A+ and Network+ or equivalent experience required.
  • MCSA/MCSE certification is desired. Thorough knowledge of Microsoft Windows 7/10 and Windows Server 2008/2012 installation and administration
  • Network concepts such as the TCP/IP stack, network design and troubleshooting, network security, switch and router configuration, network cabling, and secure remote access protocols
  • Telecommunications concepts such as VoIP, PRI, T1, MPLS, and CoS (Shoretel experience preferred)
  • Data center concepts such as rack and cabinet management, cable management, hardware installation, environmental control, and power protection
  • Shared storage concepts such as NAS/NFS, SAN/iSCSI, and RAID
  • Virtualization concepts such as virtual hardware, resource pooling, and the virtual machine lifecycle (VMware experience preferred)
  • Microsoft Active Directory concepts including user and group management, OU design, file permissions, user rights management, and Group Policy
  • Microsoft Office 365/Exchange management administration experience and security required
  • Working knowledge of backup system design and management (Veeam experience preferred)
  • Microsoft SharePoint concepts such as libraries, lists, sites, workspaces, workflows, and ability to form libraries as well as management of security, performance, and governance
  • Microsoft SQL Server concepts such as database management, backup and recovery, security, and performance tuning
  • Proficiency with Microsoft Office to create presentations, project plans, tables, charts, and graphs
  • Working knowledge of cGMP, SOX 404 and FDA CFR Part 11 Compliance
  • Demonstrated analytical, interpersonal, and communication (written and verbal) skills
  • High level of flexibility, with strong abilities in time management and prioritization
  • Detail oriented and well organized with the ability to work independently and under tight deadlines

This position can pay a very competitive base plus bonus, stock and benefits.

If interested and more importantly if you feel/are qualified, please send your updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately.


Sr. Systems Analyst, Hedge Funds

This is a perm position and for qualified candidates, relocation and Visa sponsorship is available.

Keys to this position

Domain knowledge: A strong understanding of Hedge Funds and the Investment Process

Strong Systems Analyst skills

Technical – Some of the following: SQL, AWS, Tableau, Jasper, Talend, Python

Strong communication skills are required

Qualifications

Planning and analysis experience following a standardized methodology such as Agile.

Analytical experience on enhancements to existing systems.

Track-record of working with business stakeholders, engineers, analysts, and infrastructure teams to complete and deliver projects

Experience in core project managements skills including plan development, risk and budget management, team building and leadership

7+ years of proven experience delivering successful projects

Proven ability to support multiple competing priorities simultaneously

Demonstrated experience in Financial services (FS), including FS data

Must be self-motivated with the ability to work with minimal supervision

Must possess excellent verbal and written communication skills

Bachelor’s Degree in Computer Science or related discipline

Experience with large-scale complex technical projects a plus

Fund Company experience & knowledge is a strong plus

SQL, basic development skills a strong plus

Salesforce experience a plus

Applicant must meet ALL of these requirements.

Description: As member of our Funds Group Applications team, this individual will be responsible for project management, requirements, systems analysis, some development, testing, and support for the Funds Group. The role requires a well-rounded and experienced technologist, who can work well with stakeholders in Hedge Fund, US Domestic Fund and Global Fund teams to build consensus on vision and then follow-through on delivery.

Business processes focus around fund administration, service provider flows, product management, investment risk, fund events, fund oversight, net asset value (NAV) calculations, end user web site management, and interfacing with the business sponsors for the funds.

The candidate will need to demonstrate the ability to assimilate technical concepts quickly, manage multiple competing priorities and communicate and coordinate effectively across all levels of the firm. We are seeking a systems analyst with 7 plus years of experience, with key capabilities being analytical rigor, communication skills, organization, problem solving, and the ability to write clear, concise and complete functional specifications. Furthermore, the candidate will need the ability to think both operationally and strategically.

SQL, basic development skills, and understanding of salesforce is a +

Responsibilities: Collaborate with business partners to understand business workflows in detail and prioritize & complete support & enhancement as needed. Work with engineers, analysts, consultants and vendors to collaboratively solve problems and deliver solutions. Translate business needs into detailed technical specifications and designs. Provide oversight for the various phases of testing and user acceptance. Advocate for the end user at all times and proactively manage risk, impact and user experience at all times.

If interested and more importantly qualified, please send your updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately.

This position can pay a very competitive base salary plus bonus and excellent comprehensive benefits package.


Process Development Engineer-Biotech/Medical Device co.-Gainesville, FL location

My client is # 1 in their field and growing. This is a perm position and candidate must be able to work without restrictions. Relocation is available for qualified candidates. Unfortunately, Visa sponsorship or Transfer NOT available for this role.

The Process Development Engineer will lead important tasks and projects in R&D and Operations including concept and prototype development, design, verification and validation; process development and transfer to manufacturing of tissue and biologic products. This position will work concurrently with cross-functional teams to develop new products, processes and process improvements per the Company’s strategic road map in compliance with all appropriate regulations and guidelines.

The Process Development Engineer will focus on supporting development of new products and process optimization in our R&D Lab. Then, he/she will lead the transfer of developed products and implementation of process improvements to Operations and/or contract facilities. Responsibilities includes technology assessment; process development, validation and implementation; supply chain development; and troubleshooting/continuous improvement of manufacturing. This position is responsible for supporting, developing, and protecting company intellectual property, and assessing and remaining current with new developments and industry trends.

Educational Requirements / Qualifications

Bachelor’s Degree in Engineering or related discipline (Graduate degree preferred).

Three or more years of experience in regulated industry. (Medical or biotech experience preferred.).

Experience with aseptic technique and processing in clean rooms (Tissue experience preferred).

Experience with process or equipment validations.

Experience in process troubleshooting and/or continuous improvement.

Experience contributing to NPD projects from concept through commercialization.

Working knowledge of medical device requirements for Class I, II and III preferred.

Background in tissue engineering and regenerative medicine.

Primary Responsibilities

The specific duties of the Process Engineer include but are not limited to:

Support development of tissue and biologics product and process optimization initiatives by developing new processes and process improvements in our R&D Lab.

Lead the transition of R&D processes to Operations and/or external contract facilities including:

Develop process validation and implementation plan.

Coordinate schedule with Operations for pilot and validation runs.

Manage budget for process implementation.

Coordinate with Commercialization Team to schedule production of new products for pre-clinical and clinical evaluation, product launch and product ramp up.

Support and guide Regulatory/Quality with Process Validation (e.g., IQ, OQ, PQ) protocols and reports and regulatory submissions.

Lead cross-functional team in conducting process hazard analysis (e.g., Process FMECA).

Lead efforts for optimization of existing tissue/biologic processes including:

Conduct capability studies and designed experiments to determine manufacturing process capability.

Collaborate/negotiate with external suppliers to develop custom processing equipment and advanced analysis/inspection methods.

Develop implementation plan for process improvements aligned with regulatory constraints and production schedule

Provide day-to-day coordination of project activities; create and maintain project schedules, timelines, budgets, and resource requirements.

Interface with Marketing/Sales, physician end users, and hospitals to understand customer requirements and critical product features. Gather, develop and document medical product specifications; identify competitive products/procedures; assist with product positioning decisions.

Maintain adequate records of formulae, process methods, and product procedures. Document and report assigned product and process development studies in a timely manner.

Support the development and protection of company Intellectual Property through new invention disclosures, identification of potential licensing opportunities, and technical assistance with ongoing patent prosecution.

Maintain proficient knowledge of tissue and medical device safety standards and regulations, and provide input into product design and testing decisions.

Perform other duties as assigned by Supervisor. Comply with all company policies, procedures, and SOPs’.

If interested and more importantly qualified, please send your updated resume with contact info to vince@techedgerecruiting.com and you will be contacted immediately.

This position can pay a very competitive base salary plus bonus and excellent comprehensive benefits package.


Lead Java Developer-

My client is a well established and growing financial services company based in the greater Boston, MA area.

Keys to this position

We are seeking a Full Stack Java Developer.  We are seeking a strong hands-on technical lead with excellent communication and problem-solving skills.

Java stack:  Core Java, multi-threading, Spring, Web Services

Leadership skills are required.  This individual will lead projects and consultants (mostly off shore).  Architect Solution and Delivery skills are key.

Strong communication skills are required.

Hands-on focus, attention to detail, ability to innovate, ability to work in fast-paced settings, pride in workmanship, and a sense of ownership. Financial services experience is a plus, not a requirement.

Responsibilities

Lead team of engineers and consultants to deliver solutions for improving the investment workflow.

Interact with Systems Analysts and Investment professionals at all levels of the organization to proactively identify opportunities for new/improved systems to improve the investment process.

Provide implementation of business process improvements involving (but not limited to) interactive data, investment process efficiency, and simplifying investor work flow.

Qualifications

7 years of experience as a software developer and application lead supporting complex application development life cycles

Experience managing small teams including offshore members

Strong understanding of JavaScript UI technologies and mobile including frameworks such as Angular, React, or Bootstrap

Very strong command of Java technologies including a deep understanding of concurrent programming concepts and the java memory model

Solid high-level understanding of current technology landscape including the current players in UI, mobile, the cloud, databases, big data, caching, and security

Working knowledge of standard java frameworks and libraries including Spring, JAXB, Jersey, Jackson, Apache Commons, etc.

Strong analytical and communication skills, both written and verbal are required.

Working knowledge of SQL and SQL performance tuning.   Direct experience with Oracle is a plus.

Experience with Amazon Web Services is a strong plus

Must be comfortable with test driven development, continuous integration, and agile development methodologies.

Bachelor’s Degree in Computer Science, engineering, sciences, or related field.

Experience in Financial Industry is preferred

Strong understanding of Equity, Fixed Income, and Derivative Instruments is desirable

 

This position can pay a very competitive base salary plus substantial bonus and profit sharing bonus and benefits.

If interested and more importantly qualified, please send your updated resume with contact info to vince@techegderecruiting.com and I will contact you immediately.

My client will sponsor your H1B Visa or transfer.

Relocation is available for qualified candidates.


Sr. Java Developer (Java, Spring, JavaScript, AWS)

My client is a well established and growing financial services company based in the greater Boston, MA area.

keys to this position

This is a highly visible role with a potential to lead the entire software engineering team consisting of 10+ onshore and offshore resources. (combination of developers and QA).

Full Stack Technologies:  Java, Spring, JavaScript, ReactJS, AWS, PostgreSQL, etc.  Hands-on coding, design and architecture.  Very strong Java skills are required.  AWS is also important.  We will look at other web front end experience.

Strong communication skills are required to effectively interface with other teams and to lead the consultant group.

technical Qualifications

7+ years of hands-on software design and development experience in commercial environments.

5+ years of demonstrated experience developing Web Applications and Services using JAVA, Spring, and other related technologies, preferably in an Agile environment, and/or

Demonstrated experience developing Web Front Ends using JavaScript, ReactJS, CSS, and other related technologies.

Demonstrated expertise in database technologies (Oracle/Postgres) with strong SQL and Excel skills.

Demonstrated experience with XML, JSON, shell scripting and UNIX/Linux.

Experience with Build tools like Maven, Gradle, Jenkins and Sonar.

Knowledge of common design patterns and their application.

Experience with, and demonstrated understanding of modern software development and DevOps methodologies.

Experience with cloud services such as Amazon Web Services is a strong plus.

This position requires proficiency and experience in software development using Java and Web based technologies. While prior business domain knowledge is not mandatory, any experience in the financial industry will be a plus.

 responsibilities

Collaborate with a team of globally distributed staff and consultants to deliver world class software solutions.

The role requires hands-on development, problem resolution and knowledge of various horizontal and vertical packages – spanning across all layers in the technical stack.

Work with business team members, project managers/analysts, other software engineers to review and qualify business requirements, functional specifications, use-cases, and test plans.

Design, prototype and author code for software components and applications based on functional specification and optimize them for system performance.

Provide technical direction to both onshore and offshore development team members with regards to iteration planning, release planning, and work prioritization across all Benchmark applications

Partner with application/data architects as well as other application teams to implement solutions and ensure effective integration with downstream systems.

Demonstrate strong technical architecture and leadership skills with ability to handle multiple activities in a dynamic fast paced environment.

This position can pay a very competitive base salary plus substantial bonus and profit sharing bonus and benefits.

If interested and more importantly qualified, please send your updated resume with contact info to vince@techegderecruiting.com and I will contact you immediately.

My client will sponsor your H1B Visa or transfer.

Relocation is available for qualified candidates.


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