Advanced Manufacturing Engineer - Medical Device (Bedford, MA)

PhilipsBedford, MA
$107,000 - $170,000Onsite

About The Position

Support production operations by driving process improvements, equipment validation, troubleshooting, and continuous improvement initiatives that enhance quality, efficiency, and manufacturing performance.

Requirements

  • 5+ years of experience supporting manufacturing operations, process validation, production engineering, manufacturing engineering, or related engineering functions in a manufacturing environment.
  • Experience supporting production teams and executing process improvements is required.
  • Root Cause Analysis, process troubleshooting, continuous improvement, manufacturing process development, equipment qualification, and process validation skills.
  • Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline or equivalent experience.
  • Analytical problem solver with strong communication and collaboration skills who enjoys working cross-functionally to improve manufacturing processes.
  • Comfortable supporting a fast-paced production environment, managing multiple priorities, and driving continuous improvement initiatives through data-driven decision-making.
  • Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

  • Experience in regulated industries such as medical devices, pharmaceuticals, biotechnology, or other highly controlled manufacturing environments is preferred.
  • Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities is highly preferred.
  • Knowledge of Lean Manufacturing, Six Sigma methodologies, statistical analysis, and manufacturing data analytics is beneficial.
  • Coding experience, artificial intelligence (AI) tools, Python, SQL, Power BI, automation technologies, or other digital manufacturing tools.

Responsibilities

  • Support daily manufacturing operations by troubleshooting production processes and equipment issues, identifying root causes, and implementing sustainable corrective actions to minimize downtime and improve productivity.
  • Lead and support process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring equipment and manufacturing processes meet quality and regulatory requirements.
  • Partner closely with production, quality, maintenance, and engineering teams to improve yields, cycle times, product quality, and overall manufacturing performance through data-driven process improvements.
  • Develop, maintain, and improve manufacturing documentation, work instructions, validation protocols, and technical procedures while ensuring compliance with applicable quality and safety standards.
  • Drive continuous improvement initiatives by analyzing manufacturing data, identifying opportunities for optimization, and implementing solutions that improve efficiency, reliability, and operational excellence.

Benefits

  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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