The Senior Process Development Engineer will develop production processes that enable product scale-up and technology transfer from R&D into manufacturing. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Development of existing and new manufacturing processes (manage, communicate, document, analyze, train)
- Perform upstream processing and ensure scalability of operations during process development.
- Interface cross-functionally with research and development, sales, marketing, supply chain, quality, and manufacturing teams to define technical requirements, develop processes, and prepare documentation.
- Execution of Process Qualifications
- Generation of Process Risk documentation
- Identification, procurement, installation, and qualification of manufacturing equipment
- Transfer of new processes and designs into the production environment
- Identification of new technologies to improve efficiency, enhance quality, and reduce costs of existing and new products.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Investigation of the IP landscape for confirmation of freedom to operate with respect to the processes being developed.
- Minimum of 5+ years’ experience working in medical device industry; disposable device experience desired, preferably with catheters and delivery sheaths.
- Four year degree in relevant discipline
- Experience with reflowing, bonding, braiding, injection molding, and various other processes required for the assembly and production of complex, disposable medical devices.
- Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required.
- Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Strong attention to detail including analytical and problem-solving skills.
- Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
- Proficiency with Solidworks and designing fixturing and equipment
- Deep knowledge in the application of statistical techniques to process development and improvement.
- Previous start-up experience, a plus, but not required.
- Proven track record of working with design engineers to reduce costs and improve a design for manufacturability
- Light work, exerting up to 20 lbs. of force or less.
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
- Requires fingering, repetitive motion, talking and hearing.
- Significant work pace & pressure due to deadlines
To apply, please submit your resume and cover letter documents below.
|Position reports to:||Engineering Manager|