Senior Product Development Engineer

What we are looking for:

The Biomaterials Product Development Engineer drives the development, validation, and commercialization of custom biomaterial components supporting the medical device and pharmaceutical industries, with activities including new designs, material conversion, process optimization, process qualification and quality compliance. This position works intimately with the R&D team and regularly interfaces with business development, clients, contract manufacturers, operations, and quality engineering to deliver tasks and quality documents in accordance with the integrated product development process (IPDP).

What you will do:

• Lead and manage multiple projects for Research and Development in various stages of the product lifecycle in line with agreed commitments to respective clients.
• Collaborate with Research and Development team to gain fundamental understanding of materials and processes to effectively ready technology for transition to New Product Development.
• Partner with scientists to develop processes such as coating, formulation, mixing, dispensing, foaming, thermal processing, cross-linking, API handling, polymer synthesis to develop scalable processing techniques as needed for client’s end application.
• Partner with cross-functional teams to facilitate projects through development cycle with ultimate transition of manufacturing process to Operations per IPDP.
• Design processes that are scalable to a production environment based on client inputs and volume requirements.
• Communicate manufacturing and process development status, expectations, and constraints to both internal and external stakeholders.
• Documents all project phases per IPDP and quality compliance. Compile, maintain, review and interpret product development data.
• Authors SOPs, Work Instructions, Batch Records, Product Specifications, Process Performance Qualification, Process Operational Qualification protocol plans and reports critical to Product development.
• Support Business managers with technical inputs to customers for early development programs and support Quality Assurance team with any non-conformance investigations as a subject matter expert.

Who you are:

• Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Engineering, or related discipline with 5 years of relevant experience.
• Experience with Pharmaceutical Quality by Design (QbD) and/or FDA Design Controls
• Experience managing technical projects.
• Ability to leverage company’s technical competencies to address customer’s needs, and leverage companies how the needs relate to the scope of the project and how changes will affect other systems.
• Ability to translate client inputs into engineering requirements.
• Ability to explain technical concepts to internal and external project stakeholders, including process capabilities, limitations, and areas for improvement.
• Excellent interpersonal skills with proven ability to get work well with others in a team environment.
• Excellent organization and decision-making skills.
• Experience in technical writing and use of statistical tools, including Minitab.
• Proficient with MS Excel, MS Word, MS Project, and MS PowerPoint.