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Sr Product Development Engineer - Test Method Development jobs in United States
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Resolution Medical · 12 hours ago

Sr Product Development Engineer - Test Method Development

Resolution Medical is focused on developing innovative medical devices, and they are seeking a Senior Product Development Engineer specializing in Test Method Development. The role involves leading product design and development projects, ensuring compliance with requirements, and managing the execution of reliability tasks while serving as a technical resource across departments.
Health CareMedical Device
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Culture & Values
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H1B Sponsor Likelynote

Responsibilities

Research, design and implement new products based on customer specifications
Understand the end use of products, determine fitness-for-use of materials, and effectively advancing the specification development of new and derivative products
Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis
Prepare and present plans and schedules as Technical Project Lead
Serve 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 activities
Perform as a technical resource to all departments with a thorough understanding of related disciplines
Communicate progress and decisions to customers, associates and functional managers
Assist management in improving systems for product development, standard operating procedures, safety, quality control and training
Identify opportunities for productivity and quality improvements
Perform product/process analysis for cost reduction, quality improvement, and improved efficiency
Perform research, design and development of product assembly methods including production equipment
Contribute 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 assignments
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
Follow company policies and procedures
Design and develop simulated use models for engineering confidence testing and DVT. Specify and develop tests for product testing determining acceptability of designs to requirements
Develop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards)
Develop tooling and test equipment designs for product assembly and testing

Qualification

Test method developmentDesign verification3D CAD SoftwareMedical device experienceProduct developmentData analysisMachining practicesAssembly practicesCommunication skillsProblem-solving skillsTeamworkFlexibility

Required

Bachelor'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 Development
Ability to handle and be trusted with confidential and/or sensitive information
Strong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
Must 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 assemblies
Demonstrated ability to implement change, in a way that positively impacts overall department and company performance
Must be able to handle multiple projects simultaneously
Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
Excellent written and verbal communication skills
Able to work in a fast-paced, constantly changing environment
Ability to be flexible and to handle multiple projects in an organized, timely manner
Able to problem-solve, work under pressure, and to effectively manage stress
Ability to work overtime if needed
Ability to travel to support projects and customer requirements
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
Good engineering techniques
Knowledge of human anatomy
Knowledge of machining and assembly practices, tools and fixturing is required. Knowledge of plastic and/or metal is preferred

Preferred

Strong preference for experience in common catheter standards (e.g. ISO10555) or common active implantable device standards (e.g. ISO14708)

Benefits

Group 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 Program
Paid Parental Leave
Paid Holidays
Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.
401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.

Company

Resolution Medical

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Resolution Medical's Mission is to Provide Innovative Business Solutions to the Medical Device Industry.

H1B Sponsorship

Resolution Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (2)
2020 (1)

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
BIRD Foundation
2026-01-27Acquired
2025-10-10Grant

Leadership Team

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Steven Schmidt
Senior Advisor and Co-Founder of Resolution Medical
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Company data provided by crunchbase