Surgical Senior Product Development Engineer II

Who We Are

Iconic brands. Global locations. Extraordinary people. These elements, infused with our commitment to continuous improvement, set us apart from the competition and create a career and customer experience like no other. As a diversified technology company, we have leading positions in orthopedic solutions, industrial welding and cutting, and specialty gas regulation and control. Our products and services help improve the lives of our customers around the world. And, with over 15,000 passionate associates in offices across six continents, we advance our positive impact every day on a worldwide scale.

If you’re craving an opportunity to shape a growing global company, work with highly-motivated colleagues and make a difference right away‚ then Enovis Corporation (NYSE: ENOV) is the place for you.  Check out our current career opportunities today!

What You'll Do

Job Description Summary:

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 upper level 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.

Job Description:

• Participates as an active member of the New Product Development Team:
  • Identifies surgeon requirements and product characteristics.
  • Confers with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing and Regulatory); accepts and completes tasks as assigned.
  • Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification / validation activities, design review documentation, etc.)
  • Uses 3-D Modeling to document designs and design changes (Solidworks)
  • Compiles Design Dossiers or Design History Files
• Participates in surgeon symposia, focus groups and surgeon consultant meetings.
• Assists product development engineers and the Engineering Manager of Upper Extremities Product Development with New Product Development projects.
• Attends / leads cadaver labs for learning purposes.

Additional Job Description:

• Works with both the marketing team and customers to develop conceptual designs, typically in the form of SLA models or metal prototypes of the product and present those designs back to the customers for evaluation.
• Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.
• Develops project plans using appropriate planning software and periodically report on the progress of the project to upper management.
• Develops detail engineering drawings, CAD modeling and release through Design Change system.
• Works through internal prototype shop or contract through external vendors on developing prototypes.
• Schedules and directs product team meetings as needed in the absence of upper level product development engineers; assuring timeliness of project execution.
• Maintains existing product lines and writes Design Change notices for general product improvement.
• Relies on instructions and pre-established guidelines to perform the functions of the job.

Competency:

• To perform the job successfully, an individual should demonstrate the following competencies:
  • Analytical - Synthesizes complex or diverse information.
  • Design - Demonstrates attention to detail.
  • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics.
  • Project Management - Communicates changes and progress.
  • Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification.
  • Written Communication - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information. Writes detailed test protocols/reports.
  • Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
  • Business Acumen - Understands business implications of decisions.
  • Diversity - Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.
  • Judgment - Exhibits sound and accurate judgment; includes appropriate people in decision-making process.
  • Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly.

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.

Education / Experience:

• 6+ years of experience
• BS in Mechanical Engineering or equivalent
• Experience in medical devices and/or orthopedics preferred.
• Ability to effectively 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, 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.
• To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; manufacturing software and contact management systems.
• Experience with 3D CAD packages (SolidWorks preferred)

Work Environment:

• While performing the duties of this job, the employee is exposed to the manufacturing environment.
• While performing the duties of this job, the employee is exposed to the office environment.
• Employee is expected to work in varying environments, including office setting, mechanical testing lab, and cadaver lab.
• The noise level in the work environment is usually moderate.

Physical Demands:

• While performing the duties of this job, the employee is regularly required to sit, talk and hear.
  • The employee frequently is required to sit and use hands to operate computer keyboard, and telephone. 
  • The employee is frequently required to stand, walk, and reach with hands and arms.
  • This position works in a typical office/manufacturing/warehouse environment.
  • The employee must occasionally lift and/or move up to 30 pounds. 
  • The noise level in the work environment is usually moderate.
  • This position works in a typical office environment. 
  • Perform job duties for 8 or more hours a day.
  • Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

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.