Digital Prospectors Senior Manufacturing Engineer in Mansfield, Massachusetts
Senior Manufacturing Engineer
Job Type: Direct Hire
Recruiter: Erin Donovan (https://digitalprospectors.com/our-team/erin-donovan)
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Job Title: Senior Manufacturing Engineer
Location : Mansfield, MA
Duration: Direct Hire
POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
The Senior Manufacturing Engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with customer specifications and quality standards. The individual will provide process development and manufacturing engineering support as a project team member during product development phases and a project team lead during manufacturing scale up regarding the introduction of new products into manufacturing through DV builds, Clinical builds and/or Commercial builds. Individual will support commercial builds and recommend/implement improvements to production processes, methods, and controls.
Key Responsibilities include, but not limited to:
Develop and oversee the execution of process validations including but not limited to IQs, OQs, PQs, Gage R&Rs, and other engineering studies, qualifications, and/or DOEs.
Develops processes that meet safety regulations and adhere to ISO 13485, QSR 21 CFR 820, GMP, and other applicable requirements.
Plans and coordinates projects of moderate scope to support manufacturing scale up including estimating schedules, staffing needs, project cost and budget.
Coordinate launches of new processes including establishing goals, training team members, and evaluating results.
Participate as a team member on new product development projects as the manufacturing representative to provide DFM input and preliminary process development.
Responsible for drafting process risk documentation including but not limited to Master Validation Plans and PFMEAs.
Represents the company on technical issues and requirements to the customer. Adapt and devise new approaches to difficult problems from standard or known techniques.
Confer with management and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production
Bachelor's Degree in Mechanical or Manufacturing Engineering or equivalent.
Minimum of six (6) years’ experience in manufacturing, preferably in the medical device industry with related materials and processes.
Demonstrated hands on experience developing manufacturing processes / applying mechanical aptitude.
Experience commercializing manufacturing processes including but not limited engineering instructions, bills of material, supply chain, capital equipment, process validation.
Excellent project and program management skills.
Computer proficiency, including CAD.
Excellent interpersonal and communication skills to work with vendors, customers, and associates.
Ability to multi-task in a fast-paced environment
Desired: Knowledge and experience with ISO 13485:2016 and FDA QSR 21 CFR 820
Make this your next career move as one of our many long-term contractors or employees!
Work as our full-time employee with full benefits (Medical, Dental, Vision, STD, LTD, PTO, Retirement, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
ABOUT DIGITAL PROSPECTORS:
Founded in 1999, Digital Prospectors is an award-winning recruiting and consulting firm that specializes in placing contract, contract-to-hire and direct hire engineers into rewarding opportunities with our impressive and ever-growing client base. We believe that all people should love their jobs.
Come see why Digital Prospectors has been voted “ Best Staffing Firm to Temp For ” by Staffing Industry Analysts, " Best of Staffing " for candidate satisfaction by Inavero / CareerBuilder.com, " Top Temporary Placement Firm " by Boston Business Journal, " Best Company To Work For " by Business NH magazine, " Excellence in IT and Engineering Staffing ” by TechServe Alliance, " Top IT Services Company " by Inc. Magazine, " Most Reliable Staffing Agency " in Forbes Magazine and " Top Ranked Staffing Firm " by Staffing Industry Analysts.
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