The Senior Manufacturing Engineer develops, implements and improves manufacturing processes in accordance with product specifications and quality standards. Recommends and implements improvements to production processes, methods and controls. Coordinates manufacturing launch of new or revised products. Mentors other on Team. Expected to be a Project Leader.
- Tooling design and process development.
- Assure product and process quality by designing test methods, testing finished products and process capabilities.
- Create and approve product drawings and documents.
- Establish and perform verification and validation activities including design verification testing, process and packaging validation and shelf-life studies
- Prepare product and process reports by collecting, analyzing and summarizing.
- Evaluate and solve production problems.
- Represent manufacturing in cross-functional teams/meeting.
- Ensure new equipment and tooling meet installation and operational qualification requirements.
- Target and implement cost reductions.
- Train employees on current and new manufacturing processes.
- Bachelors degree or related equivalent experience
- 10+ years related medical device experience
- Good communication skills
- Reading and preparing technical documentation.
- Working knowledge of standard machine shop equipment and processes.
- Expertise with medical device manufacturing equipment and processes.
- Understanding of medical and technical development.
- Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes.
- Computer skills including Word, Excel and Solidworks.
- Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams both verbally and in writing.