Sr. Product Development Engineer-Shoulders

Enovis • USA, TX

70d

About The Position

As a key member of the Surgical R&D Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Participates in all aspects of the projects from proposal to final design/release for the assigned project by performing the following duties. Works with a cross-functional product team consisting of product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design and development of surgical instruments and implants medical devices used in Total Shoulder Arthroplasty.

Requirements

• A minimum of 8 years of design/development experience; engineering co-op or internships is strongly desirable.
• BS in Mechanical Engineering, Biomedical Engineering, or equivalent.
• Knowledge of Word Processing software; spreadsheet software; internet software; contact/change management systems.
• Experience with 3D CAD packages (SolidWorks preferred).

Nice To Haves

• Experience in medical devices and/or orthopedics preferred.
• Experience working in a regulated industry preferred.
• Ability to present information and respond to questions from groups of managers, clients, and customers.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business community.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Responsibilities

• Participates as an active member of the New Product Development Team.
• Identifies and incorporates surgeon design requirements and product characteristics.
• Confers with cross-function teams (Manufacturing Engineering, Purchasing and Regulatory); accepts and completes tasks as assigned.
• Creates product designs and documentation used to substantiate those devices (risk assessments, verification/validation activities, design review documentation, etc.).
• Uses 3-D Modeling to develop concepts and mechanism design (Solidworks).
• Compiles Design Dossiers or Design History Files.
• Assuring compliance to FDA and ISO regulations and internal procedures.
• Establishing and maintaining project schedule and budget.
• Reviewing designs for feasibility, accuracy and technical soundness.
• Defining and implementing testing requirements associated with projects.
• Participate in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employees.
• Collaborate/lead other engineering personnel in formulating project plans, designs, cost estimates, and specifications.
• Assures proper preparation of documentation as required per project plans including user needs, surgeon feedback/IP, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork and other supporting engineering documents.
• Working with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development.
• Participates in surgeon symposia, focus groups and surgeon consultant meetings.
• Assists product development engineers and the Engineering Manager or Director of Shoulder Product Development with New Product Development projects.
• Attends cadaver labs for learning purposes.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees