Senior Product/Process Development Engineer

Medtronic Inc. Danvers , MA 01923

Posted 2 months ago

Careers that Change Lives

POSITION DESCRIPTION

Provide engineering leadership in the concept, prototyping, clinical evaluation, process/equipment development and production scale up of new products and components from R&D, Supply Chain, manufacturing transfers and business acquisitions. Provide leadership in the management of product transfer from R&D to Manufacturing. Provide engineering leadership in product transfers from R&D to Manufacturing. Provide engineering leadership in product line transfers from outside facilities to internal manufacturing in Massachusetts. Provide engineering leadership in product line transfers from current manufacturing to outsourced manufacturing vendors. Provide engineering leadership in scale up of component manufacturing for other businesses within Medtronic. Provide engineering leadership for development and scale up of low cost manufacturing for legacy product lines. Define equipment, process, material and operator specifications for manufacturing. Approach all engineering activities with the objective to reduce variability in operator, materials, machines and manufacturing processes to improve profitability at the Danvers site. Ensures Danvers Shared Technology Center strategic objectives are met. Ensures Quality, Service, Cost and Technology expectations are realized for our customers.

POSITION RESPONSIBILITIES

  • Insure compliance to Corporate, Divisional and Site Process Validation procedures and policies.

  • Insure compliance to Corporate, Divisional and Site Equipment Design/Development and Control procedures and policies.

  • Participate with R&D in the prototype development and clinical phases of new product introduction. Participate in Design for Lean Sigma activities.

  • Provide a project leadership role with R&D in the commercialization phase of major new product introductions.

  • Lead Process and Tooling Development efforts with an end goal of successfully completing Process Ranging, Characterization and Validation in support of achieving commercialization objectives and timelines.

  • Provide a project leadership role with outside organizations in the transfer of manufacturing to the Massachusetts facilities.

  • Provide a project leadership role with outside organizations in the transfer of manufacturing from the Massachusetts facilities to outsourced manufacturing vendors.

  • Generate and manage project documentation according to prescribed policies and guidelines.

  • Conduct Team meetings and Design Reviews in conjunction with assigned projects.

  • Work with the tooling engineers and machine shop to design, build and implement new tooling in support of manufacturing ramp up and transfer.

  • Evaluate proposed designs and processes for manufacturability with associated recommendations for improvements.

  • Manage engineers and technicians in accomplishing project goals.

  • Develop and/or Approve product and process specifications, generate E-Specs, QC Specs, material specs, incoming specs in support of new product introduction.

  • Provide detailed project plans and updates as required. Manage projects to meet agreed upon timelines.

  • Lead or assist in Complaint and Failure Investigations where expertise dictates involvement.

  • Using influence management skills interface with engineering, materials control, planning, finance, document services, marketing and manufacturing in setting and achieving common project goals.

  • Prioritize and balance workload of multiple project assignments based on business and functional objectives.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Analyzes, researches, designs and develops materials and their related fabrication and application processes to develop and optimize materials for use in engineering design of and/or application in structures, systems and subsystems.

  • Applies principles of chemistry, physics, and material behavior to develop metallic, non-metallic and composite material and processing specifications, fabrication and assembly processes.

  • Develops, analyzes and applies material properties and design allowables, processing processes and quality engineering specifications.

  • Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications.

  • May review and approve subcontractor material processing procedures.

Must Have: Minimum Requirements

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Bachelor's Degree Required

Nice to Have

  • Bachelor's degree in engineering discipline

EXPERIENCE

  • 5+ years with BS
  • 3+ years with MS

SPECIALIZED KNOWLEDGE REQUIRED

  • Ability to lead a team.

  • Ability to work on a Team

  • DOE, SPC, FMEA, GMP, ISO, 6 Sigma

  • AutoCAD or Solid Works Proficiency

  • Knowledge of Statistical Software and Practices

  • Knowledge of Materials and Related Processes

  • Technical Writing Skills

  • Verbal, Written and Presentation Skills

  • Interpersonal and Project Management Skills

DESIRED/PREFERRED QUALIFICATIONS

  • MS in engineering discipline

  • Medical device experience

PHYSICAL JOB REQUIREMENTS

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, lift, and reach with hands and arms. Specific vision abilities required by this job include normal vision.

  • Some travel as needed

Some international travel as needed

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.


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Senior Product/Process Development Engineer

Medtronic Inc.