Principal Manufacturing Engineer

Medtronic; Danvers (MA); On-site; USD 130,000 - 178,000; Full time

Job summary

A leading company in the medical technology space is seeking a Principal Manufacturing Engineer based in Danvers, MA. The role involves designing manufacturing processes, managing production layouts, and ensuring compliance with industry regulations. Candidates must have a Master's Degree and significant experience, along with proficiency in CAD software and methodologies like Lean and Six Sigma. Attractive benefits package included.

Benefits

Health, Dental and Vision Insurance

401(k) plan with employer contribution

Tuition assistance/reimbursement

Paid time off and holidays

Employee Stock Purchase Plan

Qualifications

• Master’s degree in relevant engineering field required.
• Minimum 5 years' experience in manufacturing engineering.

Responsibilities

• Responsible for designing manufacturing processes and production layouts.
• Develop validation protocols and navigate regulatory requirements.

Skills

Lean manufacturing

Six Sigma methodologies

Root cause analysis

Defect analysis

Statistical Process Control (SPC)

Process Capabilities

Education

Master’s Degree in Manufacturing, Mechanical, Industrial, or Biomedical Engineering

Tools

CAD software

Job description

We anticipate the application window for this opening will close on - 13 Aug 2025

Position Description:

Principal Manufacturing Engineer for Medtronic, Inc located in Danvers, MA. Responsible for design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Design arrangement of machines within plant facilities to ensure most efficient and productive layout. Design sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance. Work to develop various validation protocols, test methods and test fixtures. Navigate various risk activities to include PFMEA (Process Failure Mode Effect Analysis) and DFMEA (Design Failure Mode & Effects Analysis). Navigate complex industry and government regulations to include ISO quality system - ISO 9001, ISO 14971, ISO13485, FDA QSR (Quality Systems Regulation) Part 820 and relevant international standards. Coordinate process validations using IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) and CAPA (corrective and preventative actions). Develop manufacturing processes and equipment at contract manufacturers and internal operations facilities. Utilize processes including Root cause and defect analysis, 5S, Statistical Process Control (SPC), and Process Capabilities for quality outcomes. Utilize various industry systems and CAD software packages. Conduct statistical analyses and work with policy stakeholders regarding risk-based sampling methodologies. Utilize Lean manufacturing and Six Sigma methodologies, incorporating GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices). *Relocation assistance not available for this position. #LI-DNI.

Basic Qualifications:

Master’s Degree in Manufacturing, Mechanical, Industrial, or Biomedical Engineering, or related engineering field, and five (5) years of experience as a Manufacturing engineer or related occupation. Must possess a minimum of five (5) years of experience with each of the following: Developing validation protocols, test methods and test fixtures; PFMEA & DFMEA; ISO 9001, ISO 14971, ISO13485, and FDA QSR Part 820; IQ/OQ/PQ and CAPA; Developing manufacturing processes and equipment; Root cause and defect analysis, 5S, SPC, and Process Capabilities; Lean manufacturing, Six Sigma methodologies, GDP and GMP; and CAD software. Relocation assistance not available for this position.

Salary: $130,600 to $177,600 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, andSimple 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), andCapital 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