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.

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About vinceter1

Onthe company side: TechEdge Recruiting delivers with a one on one approach to staffing technical hiring needs for clients throughout New England. With over 15 years of relative industry experience, we will deliver Quality versus Quantity. We have full life cycle recruiting expertise to provide you with a seamless and confidential process from initial interview set up through salary negotiations. We will respond quickly to your planned and unplanned staffing needs. In fact, we often present candidates that you may miss in your internal recruiting efforts. We thoroughly screen and extensively check credentials and references to present candidates who best match your business needs, functional requirements, and company culture. Then, we handle negotiations and monitor satisfaction. We have a diverse client base to draw from in various industries which includes High Tech, Financial Services, Life Sciences, Retail, Manufacturing, Healthcare and Government. Our goal is to provide companies with the talent they need to grow and to enhance the careers of the candidates we represent. We provide the best-suited candidates for you to screen based upon your requirements. We become a partner with your organization to provide you with the most compatible fit for your specific needs. We will make sure each candidate is well informed and qualified for your position. Companies turn to us for our expertise in understanding exactly what they seek (and because we take the time to learn what our candidates seek). We take pride in offering the most effective and discreet placement services available. Because of that, we are able to attract top notch, technology savvy, bright individuals and help them grow in great companies. You pay us NO FEE unless or until you hire our candidate. Expertise in the following areas: Database Administration/Development-Oracle, SQL Server Desktop/Help Desk Support Network & Infrastructure Engineering-LAN/WAN/SAN, Security, Firewalls, Messaging System Administration-Unix or Windows based, Linux Web Development/Software Engineering SAP/Peoplesoft Consultants SharePoint Developers, Administrators, Analysts & Architects On the Candidate side: TechEdge Recruiting works with Information Technology professionals using a one on one approach to assist in attaining your career goals. Our services are effective and discreet. We have a diverse company client base in various industries which include High Tech/Software, Financial Services, Life Sciences, Retail, Manufacturing, Healthcare and Government. Companies turn to us for our expertise in understanding exactly what they seek because we take the time to learn what our candidates seek. We are results oriented and pride ourselves in elevating the careers of talented people. We do this while helping View all posts by vinceter1

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