Principal Manufacturing Engineer

Posted Yesterday
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Danvers, MA, USA
In-Office
148K-185K Annually
Senior level
Healthtech
The Role
Lead design, deployment, operation, and optimization of the Manufacturing Execution System (MES). Define MES architecture and workflows, integrate MES with ERP, ensure GMP and 21 CFR Part 11 compliance, perform IQ/OQ/PQ validation, apply DMAIC problem solving, create digital manufacturing documentation and SOPs, monitor system performance, conduct audits, and implement controls and enhancements to support regulatory traceability and production operations.
Summary Generated by Built In
We anticipate the application window for this opening will close on - 7 Sep 2026

Position Description:       

Responsible for driving operational excellence by ensuring the successful design, development, deployment, operation, and optimization of the Manufacturing Execution System (MES). Conduct various studies pertaining to cost reduction, Return on Investment (ROI), inventory control and production record systems. Define Manufacturing Execution System (MES) architecture, configuration, and implementation of MES workflows to support production operations and regulatory traceability. Define Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment. Comply with Medical industry standards system testing and validation according to Good Manufacturing Practices (GMP), 21 CFR Part 11 requirements, regulations and quality mgmt. requirements by conducting audits and implementing controls to ensure regulatory compliance. Monitor performance of the MES system to ensure efficiency by analyzing system metrics, identifying areas for optimization and implementing system enhancements. Apply DMAIC (Design, Measure, Analyze, Improve, and Control) problem solving methodologies. Develop and maintain digital manufacturing documentation, including work instructions and process maps, within the MES framework. Conduct Installation Qualification, Operational Qualification, and Performance Qualification(IQ/OQ/PQ) system validation protocols involving test steps per production line to ensure MES compliance with regulations. Relocation assistance not available for this position.  #LI-DNI

Basic Qualifications:        

Bachelor’s Degree or foreign equivalent in Electronic Engineering, Electronics & Instrumentation, Mechanical Engineering, or related engineering field and five (5) years of progressively responsible experience as a systems engineer, electronics engineer, or mechanical engineer. Must possess at least 5 years’ experience with each of the following: Conducting studies pertaining to cost reduction, ROI, inventory control and production record systems; MES architecture, defining workflows, configuring user interfaces, and integrating with ERP; Conducting Testing, Validation and implementing controls for regulatory compliance; Monitoring, optimizing, and implementing enhancements of MES systems; DMAIC; Developing and maintaining Digital manufacturing Documentation; and Conducting IQ/OQ/PQ system validation protocols involving test steps per production line for MES compliance with regulations.

Salary: $148,000 to $184,800 per year

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

 Medtronic benefits and compensation plans

Recruitment Fraud Alert
We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:
Medtronic will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
If you suspect you have received a fraudulent offer or communication claiming to be from Medtronic, please do not respond, open any attachments, or click on any hyperlinks.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at
[email protected].

Skills Required

  • Bachelor's Degree in Electronic Engineering, Electronics & Instrumentation, Mechanical Engineering, or related engineering field (or foreign equivalent)
  • Five (5) years of progressively responsible experience as a systems engineer, electronics engineer, or mechanical engineer
  • At least 5 years experience conducting studies on cost reduction, ROI, inventory control, and production record systems
  • At least 5 years experience defining MES architecture, workflows, configuring user interfaces, and integrating MES with ERP
  • At least 5 years experience conducting testing, validation, and implementing controls for regulatory compliance (GMP, 21 CFR Part 11)
  • At least 5 years experience monitoring, optimizing, and implementing enhancements to MES systems
  • At least 5 years applying DMAIC problem solving methodology
  • At least 5 years developing and maintaining digital manufacturing documentation, work instructions, and process maps within MES
  • At least 5 years conducting IQ/OQ/PQ system validation protocols per production line for MES compliance

Medtronic Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.

  • Parental & Family Support Paid leave for birthing and non-birthing parents is positioned as notably generous, with additional Family Care Leave available for a range of caregiving needs. Fertility, adoption, donor, and surrogacy support adds depth for different paths to family-building.
  • Retirement Support A 401(k) match and an employee stock purchase plan are presented as meaningful long-term savings tools. Scholarship and tuition programs further reinforce financial security beyond salary.
  • Healthcare Strength Medical, dental, and vision coverage is consistently described as a strong part of the total rewards package. Mental health resources, critical illness coverage, and wellness supports broaden the overall health offering.

Medtronic Insights

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The Company
HQ: Dublin
80,303 Employees
Year Founded: 1949

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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