Manufacturing Engineer II

MedtronicBoulder, CO
1dOnsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Manufacturing engineering position will focus on supporting sustaining optimization projects and qualifications.  Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the validation, compilation of reports, coordinating of tasks and creating engineering change orders.  The role will interact directly with the manufacturing operators, supplier quality engineers, operations quality engineers, and design engineers to ensure proper qualification plan is followed. Manufacturing Engineer II Location: Onsite, Boulder, Colorado 100% The Manufacturing engineering position will focus on supporting sustaining optimization projects and qualifications.  Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the validation, compilation of reports, coordinating of tasks and creating engineering change orders.  The role will interact directly with the manufacturing operators, supplier quality engineers, operations quality engineers, and design engineers to ensure proper qualification plan is followed.

Requirements

  • Mechanical aptitude.
  • Strong computer skills, including Microsoft Word, Microsoft Excel, Microsoft Project, Minitab, etc.
  • Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports.
  • Knowledge of GMP and ISO regulations (Design Controls).
  • Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct
  • Must be able to work in a dynamic environment with little supervision or daily direction
  • Strong, team-oriented professional with good interpersonal skills and project management experience.
  • Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.

Nice To Haves

  • Electrical, Mechanical, or Electromechanical degree
  • Medical Device experience
  • Experience with equipment development and process validation (IQ/OQ/PQ)
  • Small tooling design and development
  • Engineering experience with medical devices
  • Design of Experiments (DOE)
  • Electro-Mechanical troubleshooting skills
  • Strong statistical skills using Minitab
  • Six Sigma Lean Manufacturing experience preferred
  • NCMR, CAPA, and Audit experience

Responsibilities

  • Develop and execute validation strategy of various changes including scrap reduction, fixture improvements, supplier changes, and equipment optimization
  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality
  • Provides guidance regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures comply with applicable regulations.
  • Ensures reliability, develops technical specifications for production, analyzes configuration and processing solutions, and tests product conformance to specifications.
  • Collaborates with research, design, development, and testing for product improvement projects.

Benefits

  • Medtronic offers a competitive Salary and flexible Benefits Package
  • A commitment to our employees lives at the core of our values.
  • We recognize their contributions.
  • They share in the success they help to create.
  • We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
  • 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
  • Simple Steps (global well-being program)
  • 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)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
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