Product Development Engineer

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.

Job Title:

Product Development Engineer

Reports To:

Manager, Product Engineering

Location:

Houston, TX

Business Unit Description:

Enovis Foot & Ankle

Role Summary:

The Product Development Engineer will primarily be responsible for the design and development of new product(s) or system(s). The engineer will work with a cross-functional product team consisting of upper-level product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design, development, and design transfer of surgical instruments and implants.

Key Responsibilities:

• Develop new/innovative process technology to anticipate the needs of the customer and maintain a competitive edge in the orthopedic/podiatric medical device industry.
• Perform market research to devise solutions to orthopedic/podiatric problems; including performing customer inquiries and analyzing existing products.
• Participate and lead product development including concept generation, feasibility testing, prototype creation, and applicable verification and validation testing.
• Conduct and oversee applicable verification and validation testing including mechanical analysis and simulated use testing.
• Prepare verification and validation protocols and reports.
• Assist in the 510 (k) and other regulatory application processes.
• Communicate with vendors regarding outsourced manufacturing for appropriate design transfer activities.
• Be aware of and comply with regulatory requirements that are applicable to Enovis, including but not limited to MDR, FDA, and ISO requirements.
• Maintain equipment by coordinating maintenance and repair services following the manufacturer’s instructions and established procedures.
• Train applicable staff on testing evaluation process associated with company product.
• Participate in quality control/assurance activities.
• Train applicable staff on the product knowledge related to sustaining activities for post market requirements including NCMR, complaint, and CAPA investigations.
• Participate in performance and process improvement activities.
• Drive design inputs based on gather user needs and marketing requirements.
• Create design outputs including, but not limited to: drawings, test plans, manufacturing and inspection work instructions, design verification and validation protocols and reports, and change orders.
• Collaborate with project management to create and manage detailed and accurate project plans and budgets.
• Communicate project updates to the cross functional team including company leadership.
• Compile and maintain product DHFs.

Minimum Basic Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's Degree in Mechanical or Biomedical Engineering (other Engineering or technical degrees are acceptable with prior medical device development experience)
• 2 years of previous experience.

Work environment | Physical demands:

• Climate controlled workspace
• Typical warehouse environment, including the ability to lift up to 40 lbs. and utilize a pallet jack.
• Physical Demands: standing, sitting, climbing, crouching/kneeling, lifting, carting, etc.

Desired Characteristics:

• Knowledge of FDA, ISO, and MDR regulations/requirements.
• Knowledge on the creation and review of engineering drawings.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills and attention to detail.
• Demonstrated experience in problem solving and process creation/optimization.
• Ability to work collaboratively in a team environment.
• Ability to work effectively with people at all levels in an organization.
• Experience in training others preferred.
• Ability to interact with multiple levels of leadership, generate clear and concise written reports, and interact with teams in problem solving activities required.
• Self-starter with the ability to work independently.
• Strong written and verbal communication skills
• Promote and maintain a safe, healthy, and ethnical work environment.
• Fosters a positive work environment and encourages collaboration among team.
• Basic knowledge and ability to use hand tools (e.g., pliers, screwdriver, hammer, wrench, etc.), power tools, and test equipment.
• Proficient in use of computers/office equipment
• Ability to read blueprints/schematics.
• Basic math and measuring skills.
• Demonstrated mechanical/electrical problem solving.
• Ability to troubleshoot complex product problems using independent judgement.
• Lean/Six Sigma experience.

“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short on creating the next generation of better together at Enovis:

 Better is... | Enovis

We offer a comprehensive benefits package which includes:

• 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

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS™

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.