Senior Advanced Manufacturing Engineer

Philips•Plymouth, MN

1d•$108,000 - $171,000•Onsite

About The Position

Drive the development and scale-up of advanced manufacturing processes that bring innovative medical devices from concept to production, supporting next-generation technologies that improve patient outcomes worldwide. Your role: You will lead manufacturing process development activities for new product introduction (NPI), driving projects from concept through production readiness with a focus on scalable, robust, and compliant manufacturing solutions. You will develop, optimize, and validate manufacturing processes—including feasibility assessments, process characterization, scale-up activities, and IQ/OQ/PQ validation execution—ensuring compliance with FDA, ISO 13485, and GMP requirements. You will support equipment strategy and implementation for new manufacturing lines, including equipment selection, specification development, qualification activities, and collaboration with suppliers and internal stakeholders. You will partner cross-functionally with R&D, Quality, Supply Chain, and Operations teams to ensure manufacturability, design robustness, and successful execution of DFM/DFA principles throughout the product development lifecycle. You will provide hands-on engineering leadership during pilot builds, NPI events, and early production phases while driving issue resolution, continuous improvement initiatives, and adoption of innovative manufacturing technologies such as injection overmolding and polymer processing.

Requirements

4+ years of experience in product/process development or manufacturing engineering within the medical device industry, including experience supporting stents, catheters, delivery systems, or other complex disposable medical devices.
Experience with injection molding, injection overmolding, tooling development, polymer processing, or related advanced manufacturing technologies preferred.
Skills include process development, process validation (IQ/OQ/PQ), NPI execution, DFM/DFA principles, manufacturing scale-up, technical problem solving, and cross-functional project leadership within regulated environments.
Experience working within regulated manufacturing environments and a strong understanding of design controls, FDA regulations, ISO 13485, GMP requirements, and risk management activities.
Bachelor’s degree in Engineering or equivalent experience required.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Self-motivated and collaborative engineer who demonstrates ownership, accountability, adaptability, and a willingness to take on broad technical challenges within a fast-paced, matrixed NPI environment.

Nice To Haves

Master’s degree in Engineering preferred.

Responsibilities

Lead manufacturing process development activities for new product introduction (NPI), driving projects from concept through production readiness with a focus on scalable, robust, and compliant manufacturing solutions.
Develop, optimize, and validate manufacturing processes—including feasibility assessments, process characterization, scale-up activities, and IQ/OQ/PQ validation execution—ensuring compliance with FDA, ISO 13485, and GMP requirements.
Support equipment strategy and implementation for new manufacturing lines, including equipment selection, specification development, qualification activities, and collaboration with suppliers and internal stakeholders.
Partner cross-functionally with R&D, Quality, Supply Chain, and Operations teams to ensure manufacturability, design robustness, and successful execution of DFM/DFA principles throughout the product development lifecycle.
Provide hands-on engineering leadership during pilot builds, NPI events, and early production phases while driving issue resolution, continuous improvement initiatives, and adoption of innovative manufacturing technologies such as injection overmolding and polymer processing.