Principal Engineer

Job TitleLeads design and development of product changes within sustaining engineering for disposable medical devices.Job DescriptionSchedule, budget, and lead engineering projects with minimal guidance. Serve as the technical expert for design change programs (e.g. suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation). Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools (e.g. dFMEA, Human Factors Engineering, statistical software, CAD). Lead the creation and maintenance of design history files. Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. May supervise engineers and/or technicians. Contribute to Vantive's intellectual property through invention disclosures and patent applications.QualificationsAdvanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.Ability to train and coach others from technical expertise.BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.5+ years of related experience in Class II or Class III disposables medical product development.Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 to $156,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.US Benefits at VantiveThis is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.Equal Employment OpportunityVantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is IllegalReasonable AccommodationVantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form LinkRecruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.