Description

The Senior Product Development Engineer drives the development, validation, and commercialization of custom device components and assemblies, including ideation, prototyping, process optimization, process qualification and quality compliance. He or she regularly works with the business development team, clients, vendors, internal operations, and quality engineering to deliver tasks and quality documents in accordance with the product development process at Polyzen.

Primary Responsibilities:

• Leads multiple projects for new product development in various stages of the product lifecycle in line with agreed commitments to respective clients.
• Communicates to management, customers, and core team members of the status of development projects.
• Collaborates with customers to identify and translate product functional requirement inputs to measurable manufacturing process outputs.
• Designs manufacturing processes that are scalable to a production environment based on customer design and volume requirements.
• Specifies tooling, fixtures, and equipment for production process at required scale and manufacturing throughput.
• Assesses manufacturing process capability and aligns with customer allowed tolerances and inspection strategy.
• Develops and qualifies appropriate test and inspection methods for key product attributes.
• Partners with a cross-functional team to facilitate a transition of manufacturing process from development groups to commercial groups while maintaining collaborative working relationships.
• Responsible for documenting all development phases per the Polyzen product development process and quality compliance. Compile, maintain, review, and interpret product development data.
• Authors SOPs, work instructions, batch records, product specifications, process performance qualification and operational qualification protocol plans and reports critical to product development.
• Supports business development team by providing technical inputs to customers for early development programs and supports Quality Assurance team with any non-conformance investigations as a subject matter expert.

Other Duties:

• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Performs other job-related responsibilities as assigned.

Qualifications

• Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline.
• At least 5 years of industry related experience in a manufacturing or product development environment
• Hands on experience with prototype fabrication and associated testing.
• Experience with manufacturing process development, qualification, and capability assessment.
• Ability to understand the client’s needs, 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 based on technical skill set.
• Ability to explain technical concepts to internal and external project stakeholders, including process capabilities, limitations, and areas for improvement.
• Ability to prioritize and delegate tasks as appropriate to meet project objectives.
• Ability to mentor junior level engineers.
• Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
• Excellent analytical, critical thinking and problem-solving skills.
• 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.
• Familiar with ISO 13485 Quality Management Standard