Principal Manufacturing Engineer
Principal Manufacturing Engineer
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$ 130600 - 177600
1 Vacancy
Job Description
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:
Masters 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: $130600 to $177600 per year
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-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:
Required Experience:
Staff IC
Employment Type
Full-Time
