Title : Senior Process Engineer
Compensation : $110,000 – $135,000 base + bonus
Schedule : 8 : 00 AM – 4 : 30 PM
Employment Type : Full-time, Exempt
Drive development, optimization, and scale-up medical manufacturing processes to support new product introductions and improvements to existing product lines in a highly regulated environment. Partner closely with operations, quality, and external stakeholders to ensure that processes meet performance, cost, and regulatory expectations.
What You Will Do :
- Lead end-to-end process development projects, from concept through validation and production handoff.
- Translate product design and functional requirements into robust manufacturing and inspection methods.
- Coordinate cross-functional project teams, managing scope, timeline, resources, and communication.
- Collaborate with operations and quality leadership to ensure adequate resourcing and seamless implementation on the production floor.
- Partner with external vendors and customers to clarify technical requirements, qualification plans, and project milestones.
- Execute process qualifications and related activities (e.g., FAI, OQ, PQ, PFMEA, control plans, MSA, PPAP) to meet internal and customer standards.
- Analyze process performance using statistical tools to improve capability, yield, and cost.
- Prepare and deliver regular project updates for engineering teams and senior leadership.
- Support vendor and customer visits, audits, and root cause analysis efforts; travel as needed.
Key Requirements :
Bachelor’s degree in Engineering7–15 years of experience in process development, manufacturing engineering, or a similar function.Experience in a highly regulated industry; medical device background strongly preferred.Background in manufacturing, contract manufacturing, or medical industries and working directly with external vendors and customers.Proven success managing large-scale projects involving capital equipment and rigorous qualification requirements.Demonstrated ability to plan, prioritize, and organize multiple concurrent projects in a fast-changing environment.Excellent written and verbal communication skills, with the ability to influence and align cross-functional teams.High attention to detail and a consistent focus on accuracy, quality, and continuous improvement.Sponsorship and relocation assistance is not available.#SMNCareersFor questions or further information on the Senior Process Engineer, please contact Leslie directly at 952-818-3275 or email Lvoit@doherty.com.