"Alerted.org

Job Title: Contract Manufacturing EngineerJob Description

This Manufacturing Engineer, will be instrumental in equipment qualification, process validations, and documentation related to manufacturing processes and equipment integration.

You will play a vital role in supporting three main production lines to ensure they are operational and ready for production.

+ 50/50 split between on-floor work and desk duties, subject to fluctuation.

+ On the floor, you will set up processes, execute protocols, and perform testing for validation reports.

+ At your desk, you will focus on writing protocols, preparing for studies, and completing various documentation tasks.

Responsibilities

+ Qualify equipment and validate processes to ensure manufacturing readiness.

+ Support the setup of new manufacturing processes and execute process protocols.

+ Conduct testing to contribute to validation reports.

+ Create and maintain comprehensive documentation, including CPK studies, engineering reports, and design of experiments.

+ Develop device master records and set up process formulas.

+ Create manufacturing assembly SOPs and work instructions for product lines.

+ Collaborate with internal teams to ensure smooth operations and process efficiency.

Essential Skills

+ Bachelor's Degree in Engineering.

+ Experience in equipment qualification and process validation.

+ Proficiency in setting up new processes and Cpk (Process Capability).

+ Strong experience in engineering documentation (Design of Experiments and SOPs).

+ Experience working within a structured QMS (ISO) or GMP/cGMP environment.

+ Minimum of 3+ years of relevant experience preferred.

"Nice to have" Skills & Qualifications

+ PFMEA experience.

+ Experience with product launches.

Work Environment

45 Hour work week typical

Hours: 7:30/8 am to 4:30/5 pm typical - flexible

The company is a West Michigan-based medical device contract manufacturer with over 25 years of operation, offering a collaborative and innovative work environment.

Job Type & Location

This is a Contract position based out of Kalamazoo, MI.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Kalamazoo,MI.

Application Deadline

This position is anticipated to close on Nov 20, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.