Sr Product Development Engineer - Test Method ...

Job Type Full-timeDescriptionJob SummaryActivities include product design and development, defining technical solutions to abstract problems, defining methods and processes, design modeling, tooling design/fabrication, equipment design/fabrication, personnel management, design verification and validation, and documentation. Manage the day-to-day execution of reliability tasks by teams and team members through monitoring progress, providing technical direction, and problem-solving solutions. Subject matter expert on test method development and design verification. Primarily by driving the testing of device, assist in design and develop innovative products & manage the product design from concept to full production.This position will lead in the execution of development projects as part of a multi-functional project team with an emphasis on the V&V activities.Essential Functions Product Development (~50% allocation): Research, design and implement new products based on customer specificationsUnderstand the end use of products, determine fitness-for-use of materials, and effectively advancing the specification development of new and derivative productsPerform data analysis (statistical and practical) and develop appropriate action plans based upon such analysisPrepare and present plans and schedules as Technical Project LeadServe as Technical leader, and cross-functional team member representing Product Development, for development projects (as assigned). Duties include task management, organize and facilitate technical team meetings, lead technical reviews, provide documentation and coordinate project activitiesPerform as a technical resource to all departments with a thorough understanding of related disciplinesCommunicate progress and decisions to customers, associates and functional managersAssist management in improving systems for product development, standard operating procedures, safety, quality control and trainingIdentify opportunities for productivity and quality improvementsPerform product/process analysis for cost reduction, quality improvement, and improved efficiencyPerform research, design and development of product assembly methods including production equipmentContribute to the development of project plans that meet the required customer and/or internal milestones, specifications, and product cost goals, within project budget and staff assignmentsSupport company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirementsFollow company policies and procedures Requirements, Verification, & Testing (~50% allocation) Design and develop simulated use models for engineering confidence testing and DVT. Specify and develop tests for product testing determining acceptability of designs to requirementsDevelop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards)Strong preference for experience in common catheter standards (e.g. ISO10555) or common active implantable device standards (e.g. ISO14708)Develop tooling and test equipment designs for product assembly and testingRequirementsFunctional KnowledgeGood engineering techniquesKnowledge of human anatomyArticulate and able to effectively communicate very technical subjects with peers and customersKnowledge of machining and assembly practices, tools and fixturing is required. Knowledge of plastic and/or metal is preferredEducation, Experience, Required SkillsBachelor's degree in related field (equivalent work experience may be considered)Five (5) + years of medical device industry experience as an individual contributor with a majority of time spent on requirements development, design verification, & test method development.Strong strategic focus in the areas of Product and Process DevelopmentAbility to handle and be trusted with confidential and/or sensitive informationStrong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely mannerMust have knowledge of machining and assembly practices, tools and fixturing (plastic and/or metal preferred)Proficiency in 3D CAD Software (preferably SolidWorks) In addition to fixture design, must be able to open, view and manipulate assembliesDemonstrated ability to implement change, in a way that positively impacts overall department and company performanceMust be able to handle multiple projects simultaneouslyMust excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive resultsExcellent written and verbal communication skillsAble to work in a fast-paced, constantly changing environmentAbility to be flexible and to handle multiple projects in an organized, timely mannerAble to problem-solve, work under pressure, and to effectively manage stressAbility to work overtime if neededAbility to travel to support projects and customer requirementsSupport company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirementsPhysical RequirementsProlonged periods of sitting at a desk and working on a computerMust be able to lift up to 25 pounds at timesMust wear gown, gloves, ear protection and other personal protective equipment when applicableAuthority and ResponsibilityAccountable for their performance and will have authority as delegated to complete their tasks and objectivesSummary of BenefitsGroup health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.Flexible Time Off ProgramPaid Parental LeavePaid Holidays Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.CompensationThe typical base pay range for this role is between $105,000-135,000/year. Compensation varies based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for an annual incentive program driven by organization and individual performance.401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.

Created: 2026-04-02