Manufacturing Engineer II

Manufacturing Engineer II

Location: Chicopee, Massachusetts (Onsite)

Role Overview

This role is responsible for developing and improving manufacturing processes, production floor layouts, and associated tools. The Manufacturing Engineer II will review new designs for manufacturability and implement process improvements to reduce product cost, decrease process cycle time, and enhance product quality.

Key Responsibilities

• Create and maintain documentation to support new and improved manufacturing processes.
• Write and perform process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as required on equipment.
• Make recommendations for equipment purchases based on manufacturing needs.
• Disposition Non-Conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs) as assigned.
• Perform experiments, such as Design of Experiments (DOEs), to characterize and improve processes.
• Interface directly with assemblers, production supervisors, leads, engineers, and management.
• Coordinate with suppliers and external resources to develop and implement new processes.
• Work closely with R&D and Manufacturing to interpret design intent for process refinement.
• Ensure personal and company compliance with all relevant regulations, policies, and quality procedures.
• Communicate business-related issues or opportunities to the next management level.
• For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices.
• Perform other duties assigned as needed.

Required Qualifications

Education: A Bachelor's degree is required. Majors such as Biomedical Engineering, Chemical Engineering, or Mechanical Engineering are suitable for this role.

Experience: 5+ years of related work experience. The ability to multi-task and operate in a fast-paced environment with minimal supervision is necessary. Experience in a medical device manufacturing environment is preferred.

Technical Skills: Experience with MS Word, Excel, and Project. Experience in Design for Manufacturing (DFM), Design of Experiments (DOE), and Failure Mode and Effects Analysis (FMEA) is required. Strong written, verbal, and interpersonal skills are necessary.

Preferred Qualifications

• Experience with CAD Software (Solid Works & AutoCAD).
• A strong Lean Manufacturing background.
• Experience in a Controlled Room environment, such as a cleanroom (CER).
• An understanding of regulations related to FDA, GMP/MDD, and ISO.

Company Overview & Culture

Our organization is a key contributor in the health and life sciences industry. We are committed to upholding the highest standards of quality and compliance. This position involves ensuring adherence to all Federal, State, and local regulations, as well as company policies and procedures related to Health, Safety, and Environmental practices.

Work Environment

Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials. Work includes potential exposure to radiation sources such as a fluoroscope in a catheter laboratory setting. Work includes potential exposure to chemicals.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at

Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

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