Principal Systems Analyst-Oracle Financials/QTC

My client is growing and currently seeking to hire a Principal Oracle Systems Analyst within its Enterprise Applications team. This is a perm position. Located in Burlington, MA area.

The ideal candidate will have a deep understanding of Oracle’s e-Business Suite and associated technologies and play a critical role in several transformative projects currently underway within the Company.

 

Responsibilities:

•Serve as the liaison between IT and the business area stakeholders to understand current and future business requirements for information technology services and systems.

•Use best practices and functional expertise within the scope of the Oracle Applications to drive change through technology and business process redesign in line with standard Oracle-based solutions.

•Participate in all phases of the Systems Development Life Cycle and Change Control processes.

•Enable continuous improvement and offer recommendations regarding opportunities to maximize integration and enable new functionality.

•Document business needs, distinguish between needs and wants, identify gaps between business needs and standard Oracle functionality, design and document solutions that fill the gaps, and provide detailed business requirements specifications for developers.

•Develop, document, and execute test plans to assess the integrity and accuracy of business processes, module functionality setups and modifications, enhancements, customizations, and patches.

•Develop and maintain end user training documentation and deliver training as required.

•Develop and maintain business process documentation and consider compliance in all business process analysis and redesign activities.

•Support, analyze, and resolve critical production application issues as required.

•Proven ability to research, understand and apply knowledge of Oracle Applications to business needs within the organization.

 

Qualifications:

•Bachelor’s degree

•8+ years of Oracle E-Business experience required (preferably release 12), specifically with Oracle Financials and Quote to Cash suite of applications

•Experience with revenue recognition and/or revenue applications

•Experience with Oracle Business Intelligence platform

•Strong understanding of functional business processes

•Experience with Oracle development tools (SQL/TOAD)

•Excellent written and verbal communication

•Ability to lead Functional initiatives with diverse teams, including gathering and consolidating requirements from cross-functional groups

•Ability to work with minimal supervision

•Ability to work under pressure and meet continually changing timelines

•Excellent analytical and interpersonal skills

•Salesforce.com experience a plus

 

This position could pay a very competitive base salary plus bonus and an excellent comprehensive benefits package.  Relocation possible for qualified candidates!

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

Unfortunately Visa sponsorship or Transfer NOT available for this role.

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Manager of Clinical Research

Job description

My client is # 1 in their market and growing. They will relocate for the right candidate. Unfortunately, Visa sponsorship or transfer is not available for this role.

Location is Gainesville, Florida area

Manager of Clinical Research-this is a perm position

The Clinical Research Manager assists in the design, preparation, planning, implementation, and review of clinical trials. As a member of the Clinical and Translational Sciences team, this position will support both sponsored and investigator initiated clinical studies with our technologies while ensuring adherence to institutional, local, federal, state, and company ethical standards. The Clinical and Translational Sciences is composed of Clinical Research, Clinical Affairs, Translational Sciences, Product Development and Professional Education. Members of the team provide scientific expertise for internal and external projects and will interface with cross-functional teams, thought leaders, academic researchers, subject-matter experts, clinicians, surgeons, and regulatory agencies. This position offers a unique combination of clinical project management and clinical affairs, in a collaborative team environment that drives results.

Job Responsibilities:

Serve as primary point of contact for assigned clinical studies.

Participate in project team meetings and provides clinical representation.

Participate in identification, evaluation, and selection of clinical study sites and investigators.

Develop, or assist with development of study design, protocols, case report forms and other study-specific documents essential to appropriate implementation of clinical investigations.

Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice. Assist with preparation and execution of Investigator meetings.

Ensure International Conference on Harmonization, and Good Clinical Practice procedures are followed in all study aspects.

Participate in vendor selection, and establish plans for data processing and data review with vendors. Manage Clinical Project Managers and/or Clinical Research Associates.

Manage Clinical Research Organizations and consultants.

Monitor clinical trials through all phases.

Ensure clinical data integrity by performing investigator and on-site training, and providing source documentation. Assist investigators by identifying issues, offering solutions, and following to resolution.

Read and critically interpret relevant literature. Serve as a resource for clinical knowledge.

Ensure timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to complete study goals.

Ensure timely, accurate collection of all adverse events, adverse reactions, and complaint reports, and implement follow-up actions.

Present information and data at investigator and team meetings.

Assist with preparation of Ethics Committee submissions and notifications/submissions to federal and state regulatory authorities.

Obtain and review all Essential Study Documents necessary for study initiation and conduct.

Draft or assist with drafting site and study budgets; participate in site negotiation and initiate site payments.

Conduct site visits and reports. Conduct pre-study, initiation, interim and close-out visits and reports.

Participate in internal and external audits. Follow company policies, procedures and standard operating procedures.

Educational Requirements / Qualifications:

Minimum of BS is Life Sciences or Mathematics.

Minimum of 2 year experience in the conduct and management of clinical trials. Industry experience preferred

Experience in Trauma/Orthopaedic/Reconstructive surgery clinical research preferred.

Strong knowledge of anatomy and physiology

Experience with protocol design, study document creation, and database design/maintenance

Strong organizational skills and attention to detail.

Ability to take ownership and drive projects to completion.

Passion for advancing scientific knowledge.

Awareness of the impact of your contributions on your team, the company, collaborators, customers, patients, medical science and society.

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 stock options and an excellent comprehensive benefits package.


Imaging Scientist

Greater Boston, MA location

Summary

This is an exciting perm career opportunity to join a talented image processing and analytics team, working on the development and commercialization of state-of-the-art medical imaging devices. We are seeking a creative Data/Imaging Scientist who wants to make a bigger impact on society through healthcare. The qualified candidate will have experience or the desire to develop advanced image processing algorithms based on both “classical” engineered features, as well as learned features (machine/deep learning). If you join our team, you will work alongside experts in several different scientific and engineering disciplines to develop imaging algorithms for registration, segmentation, detection and analysis of medical image data.

Key responsibilities:

•Explore medical image data and identify computer-detectable image features.

•Design, train and test image processing algorithms based on both classical and learned features.

•Execute diverse tasks related to the development of complete integrated systems (console, optical probes and software), from concept through commercialization.

•Participate in the development of tools for data labeling and review.

•Generate and document test protocols and engineering studies.

•Keep up to date with technology trends. Generate concepts and principles and investigate their feasibility for current and future products.

Desirable experience:

•Experience with deep learning technology stacks such as Google Tensorflow, Caffe, Theano or Torch.

•Experience/understanding of medical image formation.

•Understanding of statistical principles as applied to data science.

Equal Opportunity Employer M/F/D/V

•Optical coherence tomography, preferably swept-source and catheter-based, or a similar technology.

•Work experience within an FDA-regulated environment.

Requirements:

•Advanced degree: M.S. or PhD in relevant engineering or scientific fields (e.g. electrical/biomedical engineering, physics, mathematics, etc.).

•Proficient in signal/image processing, registration or segmentation.

•Proficient in Matlab and/or Python for data and image analysis.

•Experience with design and development of image processing algorithms.

•Experience with machine learning, deep learning or computer-aided detection as applied to images.

•Must be a self-starter and a fast learner, must work efficiently, both independently and within a team, must have very good problem solving skills and attention to details.

•Excellent written and verbal communication skills required.

•The ideal candidate should have the drive and aptitude to continuously learn about new fields and technologies and implement novel solutions to image processing problems.

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.


Associate Engineer-Medical technology company

Job description

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

Summary

The Associate Engineer will take on important tasks in new product development (NPD) as assigned by project leaders, senior engineers and scientists. This position will also contribute as a member of cross-functional teams developing processes and process improvements according to AxoGen Strategic Plan in compliance with all appropriate regulations and guidelines.

This individual will support tasks in product/process development, validation, implementation and sustaining engineering, e.g., manufacturing support, line extension development. Additional responsibilities include documentation creation and management, development testing protocols, execution of testing in R&D Lab and at contract labs and completion of reports, prototype development, process development and transfer to manufacturing of tissue and biologic products and medical devices.

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)
  • Preferred education focus in biomedical engineering, chemistry or biological sciences
  • One to three years’ experience in working as engineer in regulated industry (Product Development or R&D experience preferred)
  • Experience in tissue engineering and regenerative medicine products a plus (cleanroom processing, aseptic technique, tissue preservation, AATB standards)
  • Demonstrated hands-on technical skills.
  • Ability to work with limited supervision

Primary Responsibilities: The specific duties of the Associate Engineering include but are not limited to:

  • Contribute to technical tasks of new product development 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
  • Execute assigned hands-on tasks that include designing experiments, development of test protocols and reports, execution of testing in R&D Lab and supervision of tests at contract labs and research institutions, prototype development, design verification, validation and process development.
  • Manage release and revision of documents through AxoGen Doc. Control system/procedures.
  • 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.

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.


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.


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.


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