Unique career opportunity with a well-established firm with an aggressive growth strategy and the revenues and resources to enable it. The company has a highly successful operation developing and manufacturing high volume metal and plastic medical devices as the OEM provider of choice for major international players and topflight hospital systems.
You’ll be the key provider of manufacturing process expertise and support to R&D and Manufacturing, from concept to high volume production. Major functions include NPI, process improvement, component and material changes, implementation of design and manufacturing changes, and IQ, OQ, PQ validations that enhance products, manufacturability, quality, cost, and profitability.
Primary Responsibilities:
- Lead and/or manage projects using functional or cross-functional team members to improve performance, manufacturability, and cost of high volume, metal and plastic medical devices.
- Represent Operations in PDP efforts and in developing manufacturing strategies.
- Support the coordination and review of COGs, capacity planning models, and process validation.
- Work with customers, R&D, Marketing, and Finance to develop product pricing.
- Partner with suppliers and the R&D team on DFM and DFA implementation.
- Lead process development support on tooling and process equipment.
- Manage the development of finished goods packaging and labeling initiatives.
- Serve as a technical contributor on DFMEA and PFMEA documentation.
- Partner with R&D providing technical oversight ensuring BoMs, assembly drawings, and assembly process instructions are clearly defined.
- Participate in peer reviews and brainstorming sessions to identify opportunities for continuous improvement and mitigation of business risks.
- Interact regularly with the company’s international manufacturing operations through video conferencing, the written word, and occasional personal meetings.
Required Qualifications:
- BS or MS in Manufacturing, Industrial or Mechanical Engineering.
- 10+ years of Manufacturing Engineering experience in R&D and Manufacturing environments.
- Significant experience working for or with Contract Manufacturing Organizations.
- Exposure to precision, high volume metal forming and finishing processes and equipment.
- Familiarity with standard solid modeling, drawing, and basic statistical analysis packages.
- Knowledge of Lean principles resulting in measurable and tangible benefits to the organization.
- Familiarity with manufacturing automation tooling and processes.
- Working knowledge of DFME, PFMEA, DFM, DFA, DFT, DFS, and process validation (IQ/OQ/PQ)
- A background in needle development, technologies and production in medical devices is a plus.
- Experience with high volume injection molded plastic parts is helpful
- Strong written, oral, presentation, and organizational skills.
- Ability to negotiate with and influence stakeholders on technical and cost related issues.
- Ability to travel 5-10% domestically and internationally.