Senior Product Development EngineerParticipates 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 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.Key Responsibilities:Participates as an active member of the New Product Development Team:Identifies and incorporates surgeon design requirements and product characteristicsConfers with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing and Regulatory); accepts and completes tasks as assignedCreates 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 develop concepts and mechanism design (Solidworks)Compiles Design Dossiers or Design History FilesAssuring compliance to FDA and ISO regulations and internal proceduresEstablishing and maintaining project schedule and budgetReviewing designs for feasibility, accuracy and technical soundnessDefining and implementing testing requirements associated with projectsParticipate 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.Participates in surgeon symposia, focus groups and surgeon consultant meetingsAssists product development engineers and the Engineering Manager or Director of Shoulder Product Development with New Product Development projectsAttends cadaver labs for learning purposesTo perform the job successfully, an individual should demonstrate the following competencies:Analytical - Synthesizes complex or diverse informationDesign - Demonstrates attention to detailProblem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topicsProject Management - Communicates changes and progressTechnical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skillsOral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarificationWritten Communication - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information; writes detailed test protocols/reportsQuality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughnessBusiness Acumen - Understands business implications of decisionsDiversity - Shows respect and sensitivity for cultural differences; promotes a harassment-free environmentJudgment - Exhibits sound and accurate judgment; includes appropriate people in decision-making processSafety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properlyCurrently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future.
Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.Minimum Basic Qualifications:A minimum of 8 years of design / development experience; engineering co-op or internships is strongly desirableBS in Mechanical Engineering, Biomedical Engineering, or equivalentKnowledge of Word Processing software; spreadsheet software; internet software; contact / change management systemsExperience with 3D CAD packages (SolidWorks preferred)Desired Characteristics:Experience in medical devices and/or orthopedics preferredExperience working in a regulated industry preferredAbility to present information and respond to questions from groups of managers, clients, and customersAbility to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business communityAbility to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutationsAbility to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical analysisAbility to define problems, collect data, establish facts, and draw valid conclusionsAbility to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variablesTravel Requirements:10%Work Environment:While performing the duties of this job, the employee is exposed to the manufacturing environment as required by local ordinanceWhile performing the duties of this job, the employee is exposed to the office environment as required by local ordinanceEmployee is expected to work in varying environments, including office setting, mechanical testing lab, and cadaver labThe noise level in the work environment is usually moderatePhysical Demands:While performing the duties of this job, the employee is regularly required to sit, talk, and hearThe 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 armsThis position works in a typical office/manufacturing/warehouse environmentThe employee must occasionally lift and/or move up to 30 poundsThe noise level in the work environment is usually moderateThis position works in a typical office environmentPerform job duties for 8 or more hours a daySpecific vision abilities required by this job include close vision, color vision, and ability to adjust focus