Manufacturing Engineer

3 weeks ago

Billerica, Massachusetts, United States Michael Page Full time

About Our Client

My client is a reputable organization known for its expertise in manufacturing solutions for medical device equipment. My client is particularly well known in the diabetes space for their innovation.

Job Description

This position reports directly into the Manufacturing Manager and is responsible for:

Driving the development and enhancement of processes, utilizing statistical methods like DOEs as necessary to comprehend critical process inputs and outputs.
Overseeing the implementation of new process equipment and tooling, including developing specifications, selecting vendors, and negotiating contracts.
Participating in or leading design reviews for product components, assemblies, and manufacturing fixtures and tooling.
Conducting process validations (Installation Qualification, Operational Qualification, and Performance Qualification) and generating protocols and reports to support verification and validation efforts for product commercialization.
Creating work instructions, SOPs, technical documents, reports, raw material specifications, and drawings.
Collaborating with Operations (OPS) and Research and Development (R&D) teams to update or develop new test methods and assisting in their validation.
Providing training to technicians on new design and process development initiatives and on new test methods.
Conducting training sessions on new process development for operations and quality assurance staff.
Mentoring and offering guidance to Manufacturing Engineers and technicians. May supervising technicians or engineering interns.
Supporting Manufacturing, Quality, Regulatory, and R&D departments to ensure compliance with internal and external regulations as a subject matter expert.
Assisting in root cause analysis for design and process issues, and contributing to investigations of non-conforming products and customer complaints.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

A successful candidate will have:

Bachelor's Degree in Engineering8+ years of experience in new product development Electromechanical device knowledge R&D experience a plus Pump manufacturing experience a plusMedical device experience preferred but not required Mentoring experience preferred Strong verbal and written communication skills What's on Offer

The candidate will receive:

Competitive salary and potential for salary growthComprehensive benefits package, including health insurance, retirement plans, and vacation/sick leaveOpportunities for professional development and career advancementA positive work environment that values collaboration and innovationWork-life balance and flexible scheduling optionsAccess to cutting-edge technologies and resourcesEngaging and challenging projects that foster skill developmentSupportive and inclusive company cultureNetworking opportunities within the industryPotential for performance-based bonuses or incentives.

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