Principal Engineer, Product Transfer

Work Flexibility: Hybrid

Who we want-

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What you will do:

The Principal Engineer, Product Transfer will support high visibility global product transfer projects on neurovascular components, spanning the full range of the neurovascular product line. This position will work with suppliers to develop new manufacturing processes for existing components and will work with the Stryker cross-functional team to qualify the components for use. Some domestic & International travel required.

Technical Responsibilities:

• Independently research, design, develop, modify, and verify components, modules and sub-systems for medical devices.
• Translate user needs to design inputs/ specifications and produce complex system level designs with some guidance.
• Conduct or design advanced prototyping and testing.
• Analyze and correct complex product design issues using independent judgment.
• Develop test methods, support Gage R&R/MSAs.
• Serve as a Technical Lead for the Product Transfer organization. Lead technical governance process and independent technical review process driving engineering rigor and proactive thinking on PT projects. Provide technical mentorship to team members along with identifying technical gaps and provide solutions to remove obstacles.
• Drive right first-time approach using engineering rationale to provide solutions to remove obstacles. For process development activities drive proactive engineering rationale to develop the process in a timely efficient manner.
• Proactively identify areas of improvement/efficiency and standardization.

Business Responsibilities:

• Med Device Compliance:
• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations.
• Lead creation and refinement of engineering documentation, such as the Design History file.
• Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System.
• General Responsibilities:
• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
• Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.
• Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process.
• Deliver high quality results with passion, energy and drive to meet business priorities. Proactively seek and develop opportunities driving efficiency and speed.
• Execute technical evaluations.
• Collaborate with cross-functional teams to build partnership to achieve business objectives.

What you need:

Required:

• Bachelor of Science in Engineering, Mechanical Engineering or Biomedical, or related field.
• 8+ years of post-graduate work experience.
• Experience with engineering development, including IQ/OQ/PQ, and design verification & validation.
• A track record of contributing to successful medical device product introduction including at least one significant project from proof-of-concept through pilot production.
• Work experience in medical device and/or biotech field.

Preferred:

• Six Sigma Green Belt
• Strong technical ability to develop and optimize designs for mechanical assemblies incorporating DFM principles.
• Strong technical ability in creating engineering drawings, models, applying GD&T.
• Adept at applying knowledge of materials and manufacturing processes to product design.
• Ability to communicate moderate complexity plans and technical information to team members.
• Manufacturing or design experience with stents.
• Experience with design remediation.
• Experience with manufacturing transfers in a regulated industry.
• The ability to analyze complex situations, distill issues, develop insights, challenge the status quo, and synthesize recommendations.
• Knowledge of 21 CFR 820.30 - Design Controls and ISO 13485 section 7.3 - Design and Development.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation 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.