Engineer Principal - Electrical - Product Development - Medical Devices

SHPE Houston; Santa Barbara (CA); On-site; USD 191,000 - 290,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Life Insurance

401(k) Retirement Plan Matching

Annual Bonus

Tuition Reimbursement

Paid Time Off

Job summary

Arthrex is seeking a Principal Product Development Engineer to lead the full lifecycle development of cutting-edge medical devices, from concept to market. You will guide cross-functional teams, manage timelines and budgets, and ensure regulatory alignment to drive innovation and patient outcomes.

Ideal candidates have 12+ years in product development, strong CAD skills (Pro/E, SolidWorks), and deep knowledge of FDA/ISO medical device guidelines.

Qualifications

• Bachelor's degree (or equivalent) in Engineering (Mechanical, Biomedical, Electrical or Software) or Computer Science.
• 12 Years of experience in product development.
• MS preferred.

Responsibilities

• Designs components or systems and modifies existing designs to develop or improve products and manufacturing operations.
• Leads multifunctional product development teams through feasibility analysis, planning, execution, and budget adherence.
• Maintains design history files and supports regulatory with technical input as needed.
• Supports Marketing, Product Management and Manufacturing with technical information for training and process improvements.
• Travels as needed for trade shows, accounts and–international travel possible.

Skills

Medical device development

Project management

Regulatory knowledge

CAD design (Pro/E/SolidWorks)

Orthopedic anatomy knowledge

Manufacturing awareness

Education

Bachelor's degree in Engineering or CS

MS preferred

Tools

Pro/E

SolidWorks

Job description

Requisition ID

65398

Title

Engineer Principal - Electrical - Product Development - Medical Devices

Salary Range

Salary Minimum: $190,850.00

Salary Maximum: $289,800.00

Arthrex, a global leader in medical device innovation and orthopedic education, is seeking a Principal Product Development Engineer to lead the full lifecycle development of cutting-edge medical devices, from concept and design through commercialization and product maintenance. This is a high-impact opportunity for an experienced technical leader with 12+ years of product development experience who enjoys solving complex engineering challenges, driving innovation, and mentoring engineering teams. In this role, you'll serve as a subject-matter expert, partnering cross-functionally to bring new technologies and products to market that directly support Arthrex's mission of Helping Surgeons Treat Their Patients Better. If you're passionate about innovation, leadership, and improving patient outcomes, this is an exciting opportunity to make a meaningful difference.

Essential Duties and Responsibilities

• Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
• Recommends alterations to development and design to improve quality of products and/or procedures.
• Determines budgets and timelines for assigned projects.
• Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
• Maintains a history design file for assigned projects, adhering to Arthrex design control procedures.
• Provides Regulatory department with technical support for assigned projects as needed.
• Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
• Supports Manufacturing to provide processing improvements.
• Supports surgeon and distributor customers by training and/or educating them on technical aspects of assigned products as needed.
• Determines necessity of testing and initiates testing of assigned products
• Reports on progress and status of assigned projects on a timely basis.
• May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Knowledge

• Regularly contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.

Skills

• Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of anatomy from an orthopedic standpoint preferred.Working knowledge of joint anatomy preferred.
• Proficiency in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience preferable.
• Technical knowledge in development methodologies, design, and project implementation.
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Historical perspective on orthopedic surgery principles, theories, and products preferred.

Education/Experience

• 12 Years of experience
• Bachelor's degree (or equivalent experience) required preferably in Engineering (Mechanical, Biomedical, Electrical or Software Engineering) or Computer Science
• MS Preferred

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.