Senior Engineer – Disposables R&D, NPD

Vantive

Supports new product development initiatives for disposable medical devices at Vantive. Collaborates with global teams and adheres to FDA and international regulations.

Posted 7/24/2026full-timePlymouth • Minnesota • 🇺🇸 United StatesSenior💰 $88,000 - $121,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in product development for disposable medical products, including risk management, design control, and compliance with FDA regulations. Proficient in utilizing engineering tools and methodologies to translate user needs into product requirements and validate testing processes.

Highest-signal resume keywords

Product DevelopmentDesign Control ProceduresFDA RegulationsDesign For Six SigmaCAD Software

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Mechanical EngineeringBiomedical EngineeringPlastics EngineeringInjection MoldingExtrusionUltrasonic WeldingUV/Solvent BondingSterilizationTest Method ValidationPrototyping

Soft Skills

CollaborationVerbal CommunicationWritten CommunicationAttention To DetailOrganizational Skills

Tools & Technologies

CreoSolidworksPDM Software

Certifications & Qualifications

Design For Six Sigma Certification

Industry Keywords

Class II Medical DevicesClass III Medical DevicesISO 13485ANSI/AAMI/ISO 14971Risk Management

About the role

Key responsibilities & impact

Support or lead projects for the development of new disposable products or product extensions
Develop user needs and translate them into product requirements
Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools
Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings
Develop and execute test method validations, product testing, and verification/validation activities
Build prototypes and models
Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance

Requirements

What you’ll need

BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred
3 – 5+ years of related experience in Class II or Class III disposables medical product development
Design for Six Sigma (DFSS) training or certification preferred
Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks)
Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems
Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices
Strong collaboration, verbal and written communication skills
Strong attention to detail, organized, and able to independently manage multiple priorities
Ability to read, write and comprehend English

Benefits

Comp & perks

Medical, dental and vision insurance starting on day one
Basic life insurance, accident insurance, short-term and long-term disability, business travel accident insurance
401(k) retirement savings plan with robust investment options
Flexible Spending Accounts
Educational assistance programs
Paid holidays and paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits