Sr. Product Development Engineer-Shoulders

Enovis • Austin, TX

70d

About The Position

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. 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.

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.
• Assures compliance to FDA and ISO regulations and internal procedures.
• Establishes and maintains project schedule and budget.
• Reviews designs for feasibility, accuracy and technical soundness.
• Defines and implements testing requirements associated with projects.
• Participates in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employees.
• Collaborates/leads 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
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees