Vantive
Your Role
Leads design and development of product changes within sustaining engineering for disposable medical devices.
What you'll be doing
Schedule, 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.
What you'll bring
Advanced 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.
Experience and/or Background
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.
Equal Employment Opportunity Vantive 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.
Reasonable Accommodation Vantive 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 let us know the nature of your request along with your contact information.
Recruitment 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.
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What you'll be doing
Schedule, 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.
What you'll bring
Advanced 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.
Experience and/or Background
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.
Equal Employment Opportunity Vantive 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.
Reasonable Accommodation Vantive 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 let us know the nature of your request along with your contact information.
Recruitment 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.
#J-18808-Ljbffr