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.
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 email@example.com and you will be contacted immediately.
This position can pay a very competitive base salary plus bonus and excellent comprehensive benefits package.