Spectranetics

Advanced Manufacturing Engineer - Medical Device (Bedford, MA)

Spectranetics$107K — $170K *
Manufacturing & Automotive
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years experience in manufacturing operations, process validation, or related fields in regulated environments.
  • Strong skills in Root Cause Analysis and manufacturing process troubleshooting.
  • Familiarity with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
  • Bachelor's degree in relevant engineering disciplines or equivalent experience.
  • Knowledge of Lean Manufacturing, Six Sigma, and data analytics; coding skills in Python or SQL are a plus.

Responsibilities

  • Troubleshoot production processes and equipment issues to enhance productivity.
  • Lead process validation activities ensuring compliance with quality standards.
  • Collaborate with teams to improve manufacturing yields and cycle times.
  • Develop and maintain manufacturing documentation and protocols.
  • Analyze manufacturing data to drive continuous improvement initiatives.

Benefits

  • Generous PTO and health savings account with company contributions.
  • 401k plan with up to 7% match.
  • Stock purchase plan and education reimbursement opportunities.
  • Comprehensive benefits program with multiple options for employee well-being.
  • Supportive work environment that emphasizes collaboration and team synergy.
Full Job Description
Job Title
Advanced Manufacturing Engineer - Medical Device (Bedford, MA)

Job Description

Advanced Manufacturing Engineer - Medical Device (Bedford, MA)

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

Your role:

  • 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.

You're the right fit if:

  • You've acquired 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. Experience in regulated industries such as medical devices, pharmaceuticals, biotechnology, or other highly controlled manufacturing environments is preferred.

  • Your skills include Root Cause Analysis, process troubleshooting, continuous improvement, manufacturing process development, equipment qualification, and process validation. 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. Bonus skills include coding experience, artificial intelligence (AI) tools, Python, SQL, Power BI, automation technologies, or other digital manufacturing tools.

  • You have a Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline or equivalent experience.

  • You're an analytical problem solver with strong communication and collaboration skills who enjoys working cross-functionally to improve manufacturing processes. You are comfortable supporting a fast-paced production environment, managing multiple priorities, and driving continuous improvement initiatives through data-driven decision-making.

  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together:

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an onsite role.

Philips Transparency Details:

The pay range for this position in Massachusetts is $107,000 to $170,000

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found . 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information:

  • 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.

  • Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to Bedford, MA.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.

About Spectranetics

Spectranetics is a medical device company that develops, manufactures, and markets single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products include laser atherectomy systems, thrombectomy systems, and lead management accessories. Spectranetics was founded in 1984 and is headquartered in Colorado Springs, Colorado. In 2017, the company was acquired by Royal Philips for $2.2 billion.
Learn more about Spectranetics
Size
900 employees
Industry
Founded
1980

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