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Engineering Manager
4 months ago
Job Description:
At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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 Knee New Product Development you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title:
Engineering Manager, Knee New Product Development
Reports To:
John Green
**Location**:
Austin, TX
Business Unit Description:
Driven by Enovis’ desire to create innovative products that help improve quality of life and restore movement to those suffering from degenerative arthritis, Enovis Surgical® provides orthopedic surgeons with modern, patient-focused solutions for total joint arthroplasty. Partnerships with key surgeon consultants help provide advanced and proprietary patented solutions, including EMPOWR 3D Knee®, the only dual-pivot knee system on the market, and AltiVate Reverse® Shoulder, a market-leading system, based on the design principles of the RSP® Shoulder, which has demonstrated excellent clinical outcomes at 10 years.
Enovis Surgical offers surgeons and their patients a full range of primary and revision implants for hip, knee, shoulder, and elbow reconstructive joint surgeries, in addition to the tools and digital health technology needed in today’s changing healthcare environment.
Job Title/High Level Position Summary:
In order to facilitate the achievement of company goals, the Engineering Manager, Knee NPD will lead, manage, and ensure the successful completion of the development of products as defined by the company. This includes managing and mentoring team performance and ensuring that the engineering team is operating effectively to achieve set objectives, participating in cross-functional development teams, and collaborating with the business leadership to execute projects from concept through commercialization. The Engineering Manager, in a player / coach role, is also responsible for managing internal and external design, development, testing, and manufacturing suppliers and defining and managing the product development scope of work to ensure product safety, quality, performance, and cost requirements are met.
Key Responsibilities:
- Lead a team of biomedical engineers, mechanical engineers, and/or engineering technician(s) either direct or indirect, in developing and bringing to market, new innovative medical products, that provide true advances in clinical outcomes by:
- Identifying and documenting surgeon requirements and product characteristics
- Conferring with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing, and Regulatory); accepts and completes tasks as assigned
- Creating product designs and documentation used to substantiate those devices (i.e. risk assessments, engineering specifications, verification / validation activities, design review documentation, etc.)
- Using 3D Modeling to develop concepts and mechanism design (i.e. Solidworks)
- Compile 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
- Identify new design methods and materials to improve productivity and competency within the Product Development team
- Ability to lead product development engineers and assists the Director of Global New Product Development with New Product Development projects
- Administration of engineering personnel functions, including:
- Monitoring of team member capabilities to drive project task efficiencies
- Hiring and mentoring of engineers and support personnel in product development team
- Identify the need for and assist with hiring of new personnel
- Analyze and recommend resources needed to meet project goals
- Train new department employees on department procedures, work instructions, forms, a
