Proclinical is currently recruiting for a Medical Device Process Engineer with a biotechnology company located in Cambridge, MA.
- Participate on product & process concurrent development. Creating innovative and reliable device manufacturing process solutions aligned to the drug pipeline for device components, subassembly and final assembly. Solves complex problems through innovative and conceptual thinking with broad impact on the function; Applies technical, functional, and business knowledge to design experiments, process and/or projects that contribute to strategic direction of department/discipline/group.
- Work with design engineer and optimize design for manufacturability. Applies technical and functional knowledge to design experiments/projects that contribute to overall direction of department/discipline.
- Work with device partners, machine vendors and CMO to develop manufacturing equipment and perform FAT/SAT/IQ/OQ/PQ.
- Develop phase appropriate manufacturing process and process window through analytical, numerical, and experimental methods. Implement control strategy and continuous process verification to ensure process consistence.
- Develop, transfer, and validate test methods suitable for QC and clinical/commercial manufacturing. Recommend design for testability solution as applied.
- Create technical plan, data and reports. Uses advanced knowledge of principles, concepts and practices and/or techniques to lead complex projects within a department/ group/team that may involve other related departments/groups/teams.
- Work with internal and external manufacturing sites for process development and validation at clinical and commercial manufacturing sites.
- Participation in regulatory filings and plays critical role in write-up of regulatory filing and answering regulatory questions
- Develop relationships with other groups. Converts technical information to compelling business context and advice; Presents supportive arguments for complex ideas and projects at cross-functional meetings in a way that persuades them to adopt a different point of view, when appropriate.
- Lead technical team and/or cross-functional project team.
- Perform manufacturing and/or field issue investigation and assist issue resolution. Support Post-commercial change control.
- Continuous improvement for process efficiency and reliability.
- Regularly develops a range of visible documents and achievements, including publications, patents and internal presentations; broad expertise/ experience in scientific writing.
Skills and Requirements:
- Bachelor's Degree in Engineering required, Master's Degree preferred- plus 11+ years' experience in medical device process development or related area
- Deep knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA)
- Deep understanding of new product introduction, process development of extruded, molded and/or assembled device products as well as testing and modeling methodologies
- Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW
- Proven experience in launching of combination product through the entire development cycle in a
CMC environment is highly desired
- Demonstrated good decision-making capability and driving alignment within matrix organization
- Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base
- Complex problem-solving skill and strong hands-on experience
- Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
- Demonstrated experience of working with contract manufacturing organization to drive process development/validation and perform investigation and issue resolution
- Experience of lead technical team and cross-functional project team
- Experience with Design for Six Sigma (DFSS) is plus.
- Experience in combination product (such as autoinjector, pre?filled syringe, wearable injector, pen injector, reconstitution device etc.), implants, ophthalmology and digital health is preferred
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshars at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.