Job Title: Manufacturing Process Engineer
Job Description

The Manufacturing Process Engineer will support NPI lines and existing product lines. As new products enter the queue, this engineer will develop the manufacturing process and validation process. For existing product lines, process improvements will be needed to provide cost-effective changes. This engineer will also need to develop and update documentation to be in compliance with medical regulations. Ideally, the candidate will come from a Class III medical device company or contract manufacturer.

ResponsibilitiesSupport manufacturing of NPI lines.Develop the manufacturing and validation process for new products.Design the validation and qualification of manufacturing equipment and process changes.Work on existing lines to implement process improvements for cost-effective changes.Document changes within compliance for FDA and ISO regulations.Update BOM in accordance with regulatory requirements.Essential SkillsTroubleshootingDesign for manufacturingProcess developmentManufacturing engineeringDocumentationValidationMedical DeviceBOMIQ, OQ, PQAnalytical problem solvingSolidWorksSix SigmaLean manufacturingAdditional Skills & QualificationsExperience with Class III medical devices or contract manufacturingWork Environment

The work environment includes supporting manufacturing at two sites in Fremont, CA. One site is a contract manufacturing plant, and the other is a design and development lab. The role involves overseeing sustaining projects that are post-commercialization and exposure to new and innovative products in pre-commercialization.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.