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Sr. Design Engineer-Catheter Development

Job Description


What if you were a part of a team that makes a difference in people's lives - everyday? Take your personal and professional fulfillment to the next level at Integer. Integer is comprised of Greatbatch Medical, Lake Region Medical, and Electrochem. We make the critical components that are used in life changing medical devices. We are looking for an innovative catheter development design engineer that embodies the values that Integer operates on.


The Senior Design Engineer will be responsible for translating business needs into technical solutions across a variety of vascular device platforms. The engineering role performs assignments involving considerable responsibility including: design of medical devices and sub-assemblies, development of product specifications, analysis of engineering problems and demonstration of design compliance through verification and validation activities. The role requires close collaboration with Customers, Marketing, Management, Engineering, Regulatory, Design Assurance, and Operations, throughout the development cycle.


Accountabilities and Responsibilities:

  • 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.
  • Catheter development
  • Utilizes customer requirements to design innovative medical devices for vascular projects. Assignments may begin as initial concepts based on user needs and evolve into 'hands-on' prototyping to gain clinical design feedback.
  • Accountable for verification and validation testing to demonstrate product compliance.
  • The use of FMEA, tolerance analysis, design for manufacturability (DFM) and other methods to mitigate risk will be essential throughout the design process.
  • Provides planning inputs and executes on project deliverables to meet established metrics.
  • Utilizes design tools as required to optimize critical aspects of the design when required.
  • Develops and documents test methods to evaluate product performance.
  • Authors technical documents including but not limited to: technical memorandums, design verifications/validations, intellectual property applications, input/output matrices, and product specifications.
  • Prepares detailed engineering drawings or component specifications to define the product design.
  • Reviews product designs/drawings for compliance with applicable medical device standards, company requirements, customer contract requirements, and any other related standards.
  • Generates, reviews and approves engineering change orders.
  • Investigates root cause for product and process failures and establishes corrective actions.
  • May supervise and mentor lower level engineers, technicians, and operators.
  • Develops new and unique approaches to complex problems and advanced technology beyond previous company involvement.
  • Works in an office, lab and clean room environment.
  • Performs other duties as required.



Education & Experience:

  • Minimum Education: Bachelor's degree in related field.
  • Minimum Experience: 7+ years' experience. Catheter medical device development experience required.



Knowledge & Skills:

  • Experience with design controls, FDA/ISO regulations.
  • Depth of knowledge in manufacturing technologies, e.g. molding, extrusion, thermoforming, adhesive bonding, split die forming, hot air reflow, braiding, laser and resistance welding, soldering, wire forming, electropolishing, sterilization, etc.
  • Proficiency with mechanical CAD (SOLIDWORKS preferred).
  • Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
  • Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal and external customers.
  • Demonstrated ability to lead team activities and act as a coach.
  • Knowledge of cardiovascular anatomy and electrophysiology a plus.



Job Requirements

 

Job Snapshot

Location US-MN-Plymouth
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Other
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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-Plymouth
Kathryn LaScala
(716) 759-5600
Snapshot
Integer Holdings Corporation
Company:
US-MN-Plymouth
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description


What if you were a part of a team that makes a difference in people's lives - everyday? Take your personal and professional fulfillment to the next level at Integer. Integer is comprised of Greatbatch Medical, Lake Region Medical, and Electrochem. We make the critical components that are used in life changing medical devices. We are looking for an innovative catheter development design engineer that embodies the values that Integer operates on.


The Senior Design Engineer will be responsible for translating business needs into technical solutions across a variety of vascular device platforms. The engineering role performs assignments involving considerable responsibility including: design of medical devices and sub-assemblies, development of product specifications, analysis of engineering problems and demonstration of design compliance through verification and validation activities. The role requires close collaboration with Customers, Marketing, Management, Engineering, Regulatory, Design Assurance, and Operations, throughout the development cycle.


Accountabilities and Responsibilities:

  • 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.
  • Catheter development
  • Utilizes customer requirements to design innovative medical devices for vascular projects. Assignments may begin as initial concepts based on user needs and evolve into 'hands-on' prototyping to gain clinical design feedback.
  • Accountable for verification and validation testing to demonstrate product compliance.
  • The use of FMEA, tolerance analysis, design for manufacturability (DFM) and other methods to mitigate risk will be essential throughout the design process.
  • Provides planning inputs and executes on project deliverables to meet established metrics.
  • Utilizes design tools as required to optimize critical aspects of the design when required.
  • Develops and documents test methods to evaluate product performance.
  • Authors technical documents including but not limited to: technical memorandums, design verifications/validations, intellectual property applications, input/output matrices, and product specifications.
  • Prepares detailed engineering drawings or component specifications to define the product design.
  • Reviews product designs/drawings for compliance with applicable medical device standards, company requirements, customer contract requirements, and any other related standards.
  • Generates, reviews and approves engineering change orders.
  • Investigates root cause for product and process failures and establishes corrective actions.
  • May supervise and mentor lower level engineers, technicians, and operators.
  • Develops new and unique approaches to complex problems and advanced technology beyond previous company involvement.
  • Works in an office, lab and clean room environment.
  • Performs other duties as required.



Education & Experience:

  • Minimum Education: Bachelor's degree in related field.
  • Minimum Experience: 7+ years' experience. Catheter medical device development experience required.



Knowledge & Skills:

  • Experience with design controls, FDA/ISO regulations.
  • Depth of knowledge in manufacturing technologies, e.g. molding, extrusion, thermoforming, adhesive bonding, split die forming, hot air reflow, braiding, laser and resistance welding, soldering, wire forming, electropolishing, sterilization, etc.
  • Proficiency with mechanical CAD (SOLIDWORKS preferred).
  • Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
  • Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal and external customers.
  • Demonstrated ability to lead team activities and act as a coach.
  • Knowledge of cardiovascular anatomy and electrophysiology a plus.



Job Requirements

 
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