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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 Engineering
7–15 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.#SMNCareers
For questions or further information on the Senior Process Engineer, please contact Leslie directly at 952-818-3275 or email Lvoit@doherty.com.