Engineer II - Design Transfer - Medical Devices

Requisition ID: 60079 Title: Engineer II - Design Transfer - Medical Devices Division: Arthrex, Inc. (US01) Location: [[Santa Barbara, CA]] Salary Range: Salary Minimum: $92,000.00 Salary Maximum: $143,750.00

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineer II - Design Transfer will be responsible for full support of all new product development Design Transfer activities for cost effective and QMS compliant transfer of product design specifications (dimensional, cosmetic, functional), to full scale internal or external manufacturing production. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties and Responsibilities:

• Fully understand external regulatory and internal QMS requirements for Design Transfer.

• Review product specifications prior to finalization and recommend alterations to Product Development Engineering to improve cost, clarify requirements, establish practical inspection methodologies, and improve overall manufacturability of products.

• Facilitate effective and efficient transfer of product design specifications and functional/cosmetic requirements from New Product Development to manufacture of production equivalent samples and, subsequently, full scale production.

• Work with Product Development Engineering to identify design transfer issues and risks. Establish plans or activities for risk mitigation.

• Interact with Arthrex Manufacturing and/or external suppliers for the accurate transfer of design specifications and functional/cosmetic requirements.

• Coordinate procurement of production equivalent product for design verification and validation activities.

• Determine and adhere to budgets and timelines for assigned projects.

• Provides required Design Transfer documentation for inclusion in the Design History File for assigned projects, adhering to Arthrex Design Control procedures.

• Support Arthrex Manufacturing and/or external suppliers during scale up of manufacturing and/or inspection activities for new product launches.

• Determine necessary inspection criteria for verification of critical dimensions, features, and/or functions in order to safeguard original design intent.

• Report progress and status of assigned projects on a timely basis.

• 10-15% travel (domestic and international) may be required.

Knowledge:

• Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.

Reasoning/Ability:

• Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.

Discretion/Latitude:

• Works under very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

Skills:

• Knowledgeable of FDA and ISO guidelines for the development of medical devices required.

• Manufacturing and inspection process knowledge preferred.

• Project management and communication skills training preferred.

Reports to:

• Engineering Management

Education/Experience:

• 3 Years with BS or MS Degree in Engineering required (Manufacturing, Mechanical, Industrial, or Biomedical preferred)

About Arthrex

Arthrex Inc., a privately held company headquartered in Naples, Florida, is a global leader in orthopedic surgical device design, research, manufacturing, and medical education committed to one mission: Helping Surgeons Treat Their Patients Better. Arthrex has pioneered the field of arthroscopy and sports medicine and innovates more than 1,000 new products and procedures every year to advance minimally invasive orthopedics worldwide.

Our core value is Making People Better. As a leading health care technology innovator, we are committed to making people's lives better. The contributions we make to science and medicine have the potential to get a star athlete back in the game or improve the quality of someone's life. It's truly meaningful work.

Making People Better also signifies our corporate social responsibility and commitment to employees and communities. We make employees' lives better through job security, educational and professional growth opportunities, unique benefits and amenities, and modern facilities that promote a vibrant and dynamic atmosphere of collaboration, mutual respect, and camaraderie. We also make important economic and philanthropic contributions to the communities we serve.

As a certified Great Place to Work and one of the country's Best Workplaces for Manufacturing and Production, Arthrex is proud of its award-winning, family business culture. With more than 6,000 employees around the world, we are growing and looking for candidates who champion our Arthrex Proud values of Innovation, Integrity, Dedication, Teamwork and Competitive Spirit.

We invite you to explore our numerous exceptional benefits at careers.arthrex.com or visit us on LinkedIn, Facebook, Twitter, or Instagram.

Arthrex Benefits

• Medical, Dental and Vision Insurance

• Company-Provided Life Insurance

• Voluntary Life Insurance

• Flexible Spending Account (FSA)

• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)

• Matching 401(k) Retirement Plan

• Annual Bonus

• Wellness Incentive Program

• Free Onsite Lunch

• Gym Reimbursement Program

• Tuition Reimbursement Program

• Trip of a Lifetime

• Paid Parental Leave

• Paid Time Off

• Paid Sick Leave

• Volunteer PTO

• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.