Sr. Engineer, NPI

1 month ago

Raleigh, United States Merz North America Full time

Sr. Engineer is a product development R&D, manufacturing, and process development skilled individual that is assigned project work related to manufacturing integration of medical devices from concept to start-up manufacturing. This individual will be involved in all phases of product development as a key contributor representing product development and manufacturing. You will work with R&D, Manufacturing, Quality, Regulatory, and Marketing to ensure designs are manufacturable, evaluate potential suppliers, review new materials, and work with internal and external teams to develop, test, document, and validate the manufacturing processes, to include launch management for new products. Familiar with regulatory and quality requirements throughout all stages of product development life cycle.

Responsibilities

  • Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
  • Develop & define production control methods to monitor process output and establish critical supplier metrics.
  • Define and coordinate the design and development of manufacturing fixturing and test equipment.
  • Create Drawings, BOMs and Router documentation throughout the development cycle.
  • Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
  • Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.
  • Lead and support manufacturing development and transfers to contract manufacturers.
  • Provide input to the User Requirements and System Requirements Documents.
  • Conduct Design/Process FMEA to evaluate potential failures and implement risk mitigations
  • Product Transfer of Design to Production, including Warehousing and Service & Repair criteria documentation.
  • Ensure compliance to the requirements of ISO13485 standards, FDA/Global regulatory regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
  • Identify potential suppliers and perform technical evaluation for selection.
  • Support Supplier audits and qualifications.
  • Mentor and teach others about process development and the utilization of solid problem-solving methods and skills.
  • Problem solving and root-cause analysis
Education
  • Bachelor's Degree in ME or EE or other relevant Engineering discipline required
  • MBA / Masters in ME or EE or other relevant Engineering discipline preferred
Professional experience
  • Minimum 7-12 years of related design and manufacturing experience in the medical device and/or component development industry
  • Design Control experience including design and process verification and validation
  • Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ)
  • Injection molding, die casting, metal stamping and/or machining knowledge, including fixtures gauges and tooling experience
Knowledge, skills, and abilities
  • Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis
  • Solidworks or other CAD experience
  • Familiar with project management methods and tools


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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