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 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. As a Product Development Engineer - Hips, you will manage a specific product or group of products from product definition and planning through production and release. You will be responsible for coordinating employee recruitment, selection and training, performance assessment, work assignments, salary, and recognition/disciplinary actions. You will direct interfaces with central resources in design, process, manufacturing, test, quality, and marketing as the product(s) move to completion and distribution.
Responsibilities
- Responsible for 2D and 3D drawings, including stack analysis, aimed at the implementation of prototypes, implantable devices, instruments for Base Business devices, instrument trays and instrument sets.
- Design and technical management of custom cases with the support of Product Development team.
- Develop and manage needed documentation for the development and registration of Custom implantable components and instruments.
- Evaluation and responsibility of congruency of design Inputs.
- Actively discuss case design with surgeons and sales reps, critically evaluating components design inputs.
- Autonomously provide surgical field support for custom made products.
- Proactively communicate within Company Functions for the respect of designed products timelines, costs and quality standard.
- Proactively evaluate possible design flow implementation.
- Participate at meetings with KOL/internal and external stakeholders to collect Base Business project requirements and to contribute in preparing results presentation based on work progress.
- Analyzing Base Business project requirements and their translation into project inputs, validation, and verification requirements (IOVV).
- Responsible for ensuring the feasibility of the design and for interaction with manufacturing to transform prototypes into production.
- Responsible for the definition of technical specifications, work instructions, standard operating procedures (SOP), test plans, testing protocols, critical analysis of test reports, tolerance analysis, verification protocols for instruments sets, design change modules and implant ROM.
- Responsible for creating the required technical documentation that is required for certification renewals and geographical expansion.
Requirements
- Bachelor’s degree from an accredited college in a related discipline, or equivalent experience/combined education, with 2 years of professional experience; or no experience required with a related Masters degree.
- Medical Device industry experience required.
Nice-to-haves
- Effective communication skills.
- Demonstrated mastery of 2D and 3D drawing.
- Knowledgeable of mechanical design.
- Knowledgeable of materials for orthopedic use.
- Demonstrated knowledge of NX.
- Demonstrated knowledge of technical engineering (HMI, basics).
- Ability to adopt a can-do approach in areas of functional, ethical, and compliant behavior.
- Ability to work cross functionally.
- Ability to make complex decisions.
- Ability to go beyond existing knowledge base and to expand understanding, methods and procedures.
- Interpersonal skills.
- Exhibits attributes in passion, collaboration, partnership, rigor, transparency and communication.
- Understanding of medical language, procedures, technology and science.
- Advanced skills in precision, detail oriented and methodological FEM analysis.
- Intermediate skill level in segmentation systems knowledge.
- Technical support in the OR.
- Knowledge and understanding of the applicable laws and regulations for medical industry.
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
