Senior Manufacturing Engineer
Full Time. Louisville, CO
Bolder Surgical is seeking a Senior Manufacturing Engineer for its growing enterprise. Candidate must be versatile and flexible to work within an entrepreneurial company where you can be counted on to exceed goals successfully and quickly by utilizing strategic agility and collaboration.
- Develop, implement, and execute equipment maintenance in support of production. Report status of maintenance to management. Support regulatory audits of maintenance.
- Develop manufacturing equipment both internally and using suppliers. Manage project schedules, holding others accountable. Validate production equipment through compliant process including authoring protocols, executing protocols, and reporting results.
- Conduct root cause analysis then determine and implement corrections and corrective actions to resolve non-conformities in manufacturing. Lead projects as identified. Author, review, and approve manufacturing procedures. Lead or assist in training of manufacturing.
- Conduct design transfer with the support of the greater organization.
This unique position is an opportunity to be both hands-on and technical/strategic. It requires:
- Developing a scalable process and growing the role as the company expands
- Solid technical education as well as hands-on skills, interest, and aptitude to keep the manufacturing line going
- Technical writing
- Root cause analysis techniques
- Communication at all levels of the organization
Job Requirements and Qualifications
- Minimum BS in Engineering (mechanical/industrial preferred)
- 5-7+ years of experience
- Medical device manufacturing experience preferred
Work Environment /Other Information
- Ability to work production hours, day shift operation
- Required to regularly sit, stand, walk, lift, and reach with hands and arms, use hands and fingers, handle, feel, and be able to talk and hear.
- Specific vision abilities required by this job include close vision, and ability to adjust focus
- Work with tools, equipment, lock out/tag out, safety, etc.
- Cleanroom, warehouse, and office environment
- Travel < 5%
Bolder Surgical is a medical device manufacturer based in Louisville, CO that has redefined surgery particularly in small spaces. Founded in 2010, we have developed and are marketing laparoscopic surgical instruments including the world’s smallest low-power 3mm Vessel Sealer & Generator and the world’s first ever 5mm linear Stapler. As the company continues to bring unique, high quality products to market, activities around R&D, quality, regulatory, sales, marketing, and manufacturing are increasing dramatically. The company is well capitalized and is poised for substantial growth through the coming years.