Senior Manufacturing Engineer, NPI Design Transfer

Resonetics•Bethel, CT

About The Position

The Sr Manufacturing Engineer, New Product Introduction (NPI) Design Transfer Engineer provides support for documenting medical device component manufacturing processes for handoff from development to full scale production. This position is the bridge between R&D and manufacturing engineering. This role will utilize Resonetics’ phased design transfer process to ensure that all production release requirements are being met on schedule, including utilizing transfer checklists or project plans, and conducting phase gate reviews with functional department managers. We are looking for a more senior experienced person who could be a leader in the group. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Requirements

BS in relevant Engineering discipline.
5+ years’ experience in a manufacturing environment.
Familiarity creating and modifying drawings and models using SolidWorks.
Strong communication skills, comfortable with providing project status updates at the team level or holding phase gate meetings with functional department managers.
Demonstrated work ethic and understanding of deadline management.
Effective interpersonal skills and adeptness in working with a culturally diverse employee population.
Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.

Nice To Haves

Experience working in a medical device or regulated environment.
Prior experience transferring projects from development to manufacturing.

Responsibilities

Coordinate closely with Development and Manufacturing Engineering to define and document component manufacturing requirements and processes as devices move through the development lifecycle.
Work with cross-functional departments to confirm manufacturing line readiness and ensure appropriate equipment, space and staff are prepared.
Finalize inspection procedures including defining inspection sample size and inspection techniques/gages for each lot of parts.
Write work instructions and train production staff on procedures.
Draft process risk assessment (PFMEA), process flow charts, and control plans.
Perform process validation (IQ/OQ/PQ/MVP/TMV) and gage R&R activities, as required.
Ensure bill of materials and job router accuracy.
Solidify tooling documentation for production release using SolidWorks, including tool design updates for manufacturability and tool drawing creation/modification.
Review process metrics to identify areas of improvement during the transfer process.
Ensure that accurate and complete QMS/DMR records are generated through the change order process, including documentation of both finished components and raw materials.
Monitor transfers post-release for lessons learned or process improvements.
Provide constructive feedback to the production transfer process, and participate in continuous improvement initiatives such as creating templates for similar processes.
Assist in driving manufacturing engineering projects to completion, including making sure the work is done satisfactorily and timely.
Other duties as assigned.