What You Can Expect

The R&D Manufacturing Engineer will develop and implement manufacturing processes for the building, testing, process improvement and delivery of Patient Specific Instrumentation and Implants.

How You'll Create Impact

• Lead process development & sustaining efforts to direct functional engineering groups through process improvement and sustaining lifecycle including:
• Improve the manufacturing process for Patient Specific Instrumentation and Implants (PSI) product lines.
• Implement and improve Key Performance Indicators for the manufacturing process.
• Identify, test, and implement process improvements for creating manufacturing Work Orders.
• Identify, test, and implement process improvements for product kitting, packaging, and shipping.
• Conduct root-cause investigations and initiate corrective actions for product non-conformances.
• Support manufacturing design transfer for new product development.
• Manage relationships and partnerships with existing suppliers.
• Analyze potential new suppliers for strategic growth opportunities.
• Conduct meetings as required to resolve issues, determine status, and provide information. Ensure adequate communication between engineers and other departments.
• Ensure maintenance, safety, efficacy and compliance of existing product lines is maintained
• Perform compliance related activities to ensure compliance with company and legal policies
• Provide reports and presentations to management as required.
  

What Makes You Stand Out

Standing out means demonstrating not just technical competence, but also leadership, process ownership, and strategic thinking within a highly regulated environment. Here's what distinguishes strong candidates:

• Deep Process and Manufacturing Expertise (Orthopedic-Specific)
• Track Record of Process Improvements & Cost Reductions
• Strong Regulatory and Quality Systems Experience
• Cross-Functional Collaboration & Leadership
• Technology & Data Savviness
• Orthopedic Industry Insight
• Impact-Driven Storytelling
  

Your Background

• Requires a bachelor's degree of engineering in Mechanical Engineering, Biomedical Engineering or related engineering discipline.
• Minimum of 2 years direct experience in medical device field
• Demonstrated strong leadership style that motivates team performance by communicating a company vision and providing coaching to a team of engineers
• Experience in taking medical devices from ideation to commercialization required.
• Understanding of medical device industry regulatory requirements.
• Proven ability to plan and conduct effective meetings and group presentations.
• Proven ability and track record to handle multiple resources and priorities to meet key deadlines under pressure through effective time management skills.
• Proven track record of launching products; including timely delivery, critical thinking of project risk mitigation, cross-departmental driving, etc.
• Proven ability to lead, establish, maintain and influence effective working relationships with internal stakeholders across functional groups.
• Proficient with design control activities and verification and validation activities with respect to medical device development.
• Ability to navigate audits and FDA inspections
• Proven ability to critically review, interpret and approve technical documentation such as drawings, engineering specifications, protocols, reports, testing standards, regulatory guidance documents, safety rules, company policy and procedure manuals.
• Advanced problem solving and analytical ability.
• High proficiency in MS Office
• Effective communication and presentation skills with ability to clearly convey information and respond to questions from groups of peers verbally and in writing
• Proven ability to work in a team environment

Travel Expectations

Up to 15% of overnight travel.