Manufacturing Process Engineer
4 weeks ago
At Medical Murray, we are seeking a highly skilled Manufacturing Process Engineer to join our team. As an R&D Transfer Specialist, you will play a critical role in ensuring the smooth transfer of equipment and processes from product development to production.
Key Responsibilities:- Perform equipment and process transfer from product development to production, ensuring seamless integration and minimal downtime.
- Collaborate with R&D teams to develop and implement efficient manufacturing processes, improving product quality and reducing costs.
- Lead the transfer of products into production, following established checklists and protocols.
- Coordinate production support for transfer builds, including materials and assembly labor.
- Manage production lines during transfer builds, ensuring timely and efficient execution.
- Develop and implement manufacturing processes that meet cost targets and achieve acceptable throughput and yield.
- Train assemblers on assembly procedures during the transfer phase and support process changes that originate beyond transfer.
- Communicate with vendors to support production and address any issues that may arise.
- Manage process validation, including master validation plans, IQ, OQ, PQ, gauge R&R, and software validation.
- Perform IQ, OQ, and PQ associated with assigned projects, ensuring compliance with regulatory requirements.
- Coordinate process qualification and operational qualification of processes used in manufacturing products.
- Acquisition, setup, and installation qualification of new equipment, including creation of PM procedures as necessary.
- Support equipment maintenance, as appropriate per skills and knowledge, and manage escalation to Technology Manager.
- Engage and handoff activities to production, ensuring a smooth transition.
- Review safety issues with equipment and processes, implementing procedures and equipment modifications as needed.
- Production line layout and annual risk analysis, ensuring a safe and efficient work environment.
Requirements:
- BS in Industrial or Mechanical Engineering or equivalent.
- 3-5 years of experience with sustaining and process engineering, contract manufacturing preferred.
- ISO experience, cGMP, and ISO 13485 preferred.
Skills:
- Strong problem-solving and decision-making skills.
- High energy level, attention to detail, and a sense of urgency.
- Computer skills, including MS Office, Solidworks, or alternative CAD programs.
- Knowledge of lean manufacturing techniques.
- Skills with statistics, preferably experience with DOEs, Minitab.
- Strong customer interaction skills.
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