Senior Process Engineer

Senior Process Engineer page is loaded## Senior Process Engineer locations:
Mahwah, New Jersey time type:
Full time posted on:
Posted Yesterday job requisition :
R555599

Work Flexibility:
Onsite
** What we want:
** The MIM Engineer will lead technical efforts to introduce new medical device products using Metal Injection Molding (MIM) technology and ensure successful scale-up for high-volume production. This role combines strong mechanical engineering expertise with deep knowledge of mold design, metal injection molding, and hands-on manufacturing experience. The engineer will partner across multiple manufacturing sites and with cross-functional teams to deliver robust, compliant, and cost-effective processes that meet stringent medical device standards and high-volume output requirements.
*
* Key Responsibilities:

*** Collaborate with R&D and Design Engineering to evaluate MIM feasibility for new products.
* Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) reviews for MIM components.
* Develop and optimize MIM processes for scalability and efficiency in high-volume production environments.
* Implement automation strategies and cycle time reduction initiatives to meet production targets.
* Troubleshoot manufacturing issues and implement corrective actions during ramp-up and steady-state production.
* Process Development & Validation:
* Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards.
* Establish robust process controls and capability studies for high-volume production.
* Lead mold design activities for new product components, ensuring precision, durability, and repeatability for high-volume runs.
* Collaborate with suppliers on tooling fabrication, qualification, and preventive maintenance programs.
* Partner with Advanced Technology, Manufacturing, Quality, and Supply Chain teams for seamless technology transfer.
* Provide technical support during pilot builds, scale-up, and continuous improvement initiatives.
* Risk Management & Documentation:
* Conduct PFMEA and implement mitigation strategies for high-volume production risks.
* Maintain DHF and DMR documentation for regulatory compliance.
* Drive Lean and Six Sigma initiatives to reduce scrap, improve yield, and optimize cycle times.
* Drive design transfer and design review activities required for new product launches
*
* Minimum Qualifications:

*** Bachelor’s degree in Mechanical Engineering
* 4+ years in mechanical, process, or manufacturing engineering.
* Hands-on experience in high-volume manufacturing environments, preferably medical devices.
** Preferred

Certifications:

*** Metal injection molding, mold design, or investment casting.
* Expertise in MIM processes and tooling design for high-volume production
* GD&T, Six Sigma Green Belt, or ASME standards knowledge.
* Proven track record in NPI and technology transfer in a regulated industry.
* Proficiency in CAD software (Solid Works, Creo)
* Familiarity with validation protocols and regulatory compliance (FDA, ISO 13485).

Travel Percentage : 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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