InnoTECH Staffing is looking to hire a Senior Advanced Manufacturing Engineer with medical device experience for a client in Waltham, MA.

Candidate should be local and eligible to work in the US - there is no relocation and no sponsorship offered at this time.

This position will report to the VP, R&D.

The key things they are seeking in a candidate.

1) Experience managing contract manufacturing organizations
2) Experience supporting manufacturing operations and quality compliance (DFM, DOE, continuous process improvement, SPC)
3) Experience authoring documentation (plans, protocols, reports, test methods, work instructions, PFMEAs, CAPAs, NCMRs, regulatory submissions)
4) Experience with internal / external compliance audits
5) 7+ years in a similar role (5 years with BS and MS)
6) Recent medical device
7) Familiar with mfg process validations, transfers, change controls, and non conformances (GMP, FDA 21 CFR 820)

8)  Familiarity with leading vendor selection processes is desirable!

ESSENTIAL FUNCTIONS

• Lead downstream medical device manufacturing/commercialization efforts for product development projects

• Manage Contract Manufacturing Organizations (CMOs) and consultants, using strong interpersonal and collaboration skills

• Support manufacturing operations and quality compliance, including Design for Manufacturability, Design of Experiments, continuous process improvement, Statistical Process Control, and inventory/equipment/cost management

• Author documentation such as Plans/Protocols/Reports, Test Methods, Work Instructions, PFMEAs, CAPAs/NCMRs, and Regulatory submissions

• Utilize design skills, and experience, to identify and solve problems independently or collaboratively

• Participate in, or lead, cross-functional project teams, including management of relevant budgets and timelines

• Contribute to the definition and timely achievement of project and company goals

• Foster and embrace a culture of equity, diversity, caring, respect and continuous improvement in ourselves and our work

REQUIREMENTS

• BS degree in mechanical or biomedical engineering (or equivalent), with a minimum of 7 years relevant experience; or master’s degree with a minimum of 5 years relevant experience

• Familiar with manufacturing process validations, transfers, change controls, and non-conformances in compliance with GMP and FDA 21 CFR Part 820 and ISO 14971 guidelines (ISO 13485 and/or combination product experience is desired)

• Experience with FDA 510k commercial products (PMA product experience desired)

• Proven ability to manage the activities of contract manufacturing organizations, external vendors, and consultants

• Experience with internal or external compliance audits is desired

• Knowledgeable in scientific/engineering principles and state of the art technologies and process capabilities

• Critical thinking skills to anticipate and overcome technical or project-related risks

• Ability to work on several projects simultaneously with ability to prioritize tasks

• Team player who thrives in a dynamic cross-disciplinary environment

• Leadership experience in managing teams, direct staff, and/or external vendors

• Detail oriented written and organizational skills suited for a medical device regulated environment

• Excellent verbal communication skills and demonstrated ability to deliver effective presentations

• Proficiency in Microsoft Office. Skills in CAD (SolidWorks) and statistical software (Minitab) are desired

• Willing to travel domestically up to 20% - US and local Boston area

Compensation package includes base salary, benefits, and equity.

They are a privately held clinical stage medical device start-up of around 17 people. They are a close knit team, a highly capable team, and have fun working together to solve technical problems, and have strong VC backing.

If you are looking for an opportunity to have a lot of responsibility and visibility, career development, along with contributing to a product that has meaningful impact, with direct access / line of sight to the President, then this is for you.