Senior Manufacturing Engineer - process development, NPI - medical device

InnoTECH Staffing is looking to hire a fulltime permanent Senior Manufacturing Engineer for an exciting medical device start-up in the Greater Boston area. This requires being onsite and some travel to CM. Must be a US Citizen or Greencard holder - there is no sponsorship.

We are seeking a talented and hands-on NPI Engineer who will own the whole manufacturing process and work with external contact manufacturer.

The ideal candidate will have several years of medical device development and process development experience - ideally with a Class III product and have worked for a start-up.

Must have strong experience with process development and optimization and regulatory familiarity including working knowledge of FDA Design Controls (21 CFR 820.30) and ISO 13485.

This person will:

Lead process engineering and production support at CM partner

Develop, document, and qualify manufacturing processes for design verification, clinical builds, and commercialization, with controls and validation rigor commensurate with each phase.

Lead structured root-cause investigations on lead failures observed in builds, bench testing, accelerated aging, and in vivo studies

Review and author process procedures, change orders, equipment specifications, pFMEAs, and validation plans (IQ/OQ/PQ).

Collaborate with R&D and Suppliers to improve product robustness and manufacturability.

Would like the Sr Mfg Eng to have experience with any of the following:

• Polymer overmolding / insert molding around fine wires
• Multi-lumen extrusion handling
• Centerless grinding
• Laser welding of fine-gauge components
• Polyurethane reflow

We offer compensation package including base pay, stock options, health, dental, vision, PTO, holidays, and paid parental leave.