Sr. Process Engineer
- Provide engineering support for new product and process introductions, ensuring activities are completed and documented in accordance with new product development procedures.
- Ensure quality of process and product as defined in operational and material specifications.
- Assist in selecting components and equipment based on specifications, reliability, and regulatory requirements.
- Partner with quality engineers to develop component-specific testing and inspection protocols.
- Support capital acquisition activities including equipment specification, contract negotiation, installation, and validation.
- Analyze equipment performance, conduct experimental tests, and lead or participate in process review meetings.
- Participate in PFMEA, Control Plan, SOP, and PPAP generation for product transfers and launches.
- Complete capability studies and generate inspection documentation for in-process inspection.
- Conduct MSA studies for new products and processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Review and approve validation documentation.
- Perform additional duties as assigned.
- B.S. in Mechanical Engineering or related engineering discipline with up to 3 years of experience.
- Strong analytical and problem-solving skills with the ability to handle multiple tasks in a fast-paced environment.
- Self-starter with efficient work methods and excellent attention to detail.
- Excellent interpersonal and collaboration skills with multidisciplinary teams.
- Innovative thinker with the ability to improve processes and envision better solutions.
- Solid knowledge of manufacturing processes, materials, product, and process design.
- Ability to read and interpret complex engineering drawings with understanding of GD&T.
- Experience in an FDA-regulated or other regulated industry is beneficial.
- High level of PC proficiency.
- Occasionally lift and/or move up to 25 pounds.
- May be exposed to hazardous materials; must follow MSDS guidelines.
- May be required to wear PPE to protect against exposure to bloodborne pathogens and chemicals.
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
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