The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Myq82k67jl0lwvf8xvn

Senior R & D Engineer-Medical Devices

Job Description

The Senior Research and Development Engineer will be responsible for creating technical solutions across a variety of Cardio & Vascular projects. The engineering role performs assignments involving considerable responsibility including the development of innovative manufacturing processes with an emphasis on quality, high yields and process capability.

  • Adheres to Integer's values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Plans and executes new process development projects to meet established metrics.
  • Provides guidance for the design and engineering services departments and guides priorities for utilization of resources on new programs.
  • Interfaces with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
  • Participates in developing technical marketing strategy and direction to the company.
  • Develops new business and market opportunities with assistance when needed.
  • Develops and manages new product development NRE and product engineering budgets.
  • Develops and implements new processes for improved performance and/or cost reduction. Works closely with other departments to ensure proper implementation of new processes and designs into production.
  • Reviews, initiates, and approves engineering designs, reports, change orders, material and process specifications.
  • Investigates the use of alternate parts, materials or vendors to achieve improved performance and/or cost reduction. Maintains key technical interface with vendor base.
  • Provides technical expertise to develop new or make improvements to existing equipment with a drive to increase process efficiency/product quality.
  • Reviews product specifications for reliability; performance; design for manufacturability and test; and compliance with applicable medical device standards, company requirements, customer contract requirements, and any other related standards.
  • Supports new equipment/process implementation.
  • Collects, analyzes and presents statistical data and experimental analysis.
  • Provides cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
  • Creates and analyzes prototype products.
  • Designs experiments to provide data based conclusion about a process or product performance.
  • Recommends and rationalizes specifications for development products.
  • Provides input to risk assessment activities, e.g. FMEA.
  • May supervise and mentor lower level engineers, technicians, and operators.
  • Performs other duties as required.

Education & Experience:

  • Minimum Education: Bachelor's degree in related field. Master's degree preferred. (Materials, Mechanical, or other applicable Engineering Degree).
  • Minimum Experience: 6-10 years' experience.
  • Experience with FDA/ISO regulations.
  • Depth of knowledge or subject matter expert in materials used in cardiovascular medical devices. Specifically, nitinol, cobalt-chromium, and stainless-steel alloys.
  • Depth of knowledge or subject matter expert in manufacturing technologies associated with nitinol and other wire products, e.g. coiling, braiding, forming, heat setting, electropolishing, laser and resistance welding,
  • Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
  • Proven leadership and project management.
  • Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal and external customers.

Job Requirements

 

Job Snapshot

Location US-MN-Chaska
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Other
Apply

Company Overview

Integer Holdings Corporation

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, gender identity, marital status, or any other legally recognized protected basis under federal, state or local law. Greatbatch will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel you need a reasonable accommodation pursuant to the ADA, please contact us at 716-759-5412. Learn More

Contact Information

US-MN-Chaska
Steve Marshall
Snapshot
Integer Holdings Corporation
Company:
US-MN-Chaska
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

The Senior Research and Development Engineer will be responsible for creating technical solutions across a variety of Cardio & Vascular projects. The engineering role performs assignments involving considerable responsibility including the development of innovative manufacturing processes with an emphasis on quality, high yields and process capability.

  • Adheres to Integer's values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Plans and executes new process development projects to meet established metrics.
  • Provides guidance for the design and engineering services departments and guides priorities for utilization of resources on new programs.
  • Interfaces with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
  • Participates in developing technical marketing strategy and direction to the company.
  • Develops new business and market opportunities with assistance when needed.
  • Develops and manages new product development NRE and product engineering budgets.
  • Develops and implements new processes for improved performance and/or cost reduction. Works closely with other departments to ensure proper implementation of new processes and designs into production.
  • Reviews, initiates, and approves engineering designs, reports, change orders, material and process specifications.
  • Investigates the use of alternate parts, materials or vendors to achieve improved performance and/or cost reduction. Maintains key technical interface with vendor base.
  • Provides technical expertise to develop new or make improvements to existing equipment with a drive to increase process efficiency/product quality.
  • Reviews product specifications for reliability; performance; design for manufacturability and test; and compliance with applicable medical device standards, company requirements, customer contract requirements, and any other related standards.
  • Supports new equipment/process implementation.
  • Collects, analyzes and presents statistical data and experimental analysis.
  • Provides cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
  • Creates and analyzes prototype products.
  • Designs experiments to provide data based conclusion about a process or product performance.
  • Recommends and rationalizes specifications for development products.
  • Provides input to risk assessment activities, e.g. FMEA.
  • May supervise and mentor lower level engineers, technicians, and operators.
  • Performs other duties as required.

Education & Experience:

  • Minimum Education: Bachelor's degree in related field. Master's degree preferred. (Materials, Mechanical, or other applicable Engineering Degree).
  • Minimum Experience: 6-10 years' experience.
  • Experience with FDA/ISO regulations.
  • Depth of knowledge or subject matter expert in materials used in cardiovascular medical devices. Specifically, nitinol, cobalt-chromium, and stainless-steel alloys.
  • Depth of knowledge or subject matter expert in manufacturing technologies associated with nitinol and other wire products, e.g. coiling, braiding, forming, heat setting, electropolishing, laser and resistance welding,
  • Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
  • Proven leadership and project management.
  • Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal and external customers.

Job Requirements

 
Mwr1k875wzts0yxgjcl
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Senior R & D Engineer-Medical Devices Apply now