Product Development Engineer, (Ablation Medical Devices) jobs in United States
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TekWissen ® · 5 days ago

Product Development Engineer, (Ablation Medical Devices)

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan, offering strategic talent solutions to clients worldwide. The company is seeking a Product Development Engineer to support new platform development in Ablation Medical Devices, collaborating with cross-functional teams to enhance user requirements and drive product innovation.

Information Technology
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

The Principal Systems Engineer will be a key technical resource
This individual will support all phases of new platform development ranging from concept and technology development through commercialization and post-market support
The Principal Systems Engineer will collaborate with marketing and the medical affairs teams to create and improve user and design requirements for new platform development
This will include preclinical studies and formative studies with physicians and other key users and customers
The position will support marketing and user experience researchers by working directly with physicians and their teams to gather user needs and feedback on designs and design iterations (formative studies)
This position will help the team architect, design, select and evaluate critical system components, software architecture, prototype, test and release to production devices such as single use disposables and consoles used in Ablation procedures
This engineer will support mechanical, electrical and software architecture and development
Technologies in the devices may include touch screen display, electronic circuit boards, embedded microcontrollers, RF communications, application processors, sensors, data acquisition, pumps, valves and motor technologies
Architect, design, develop, test and transfer to production electromechanical systems and disposables for product development activities
This includes system diagrams, architecture development, GUI development, component selection and sub-system design, prototype creation, V&V activities, production tool planning and design and test fixtures for class 2 medical devices
Research product development solutions and provide analysis for product direction
Consult and solicit feedback from internal stakeholders to identify customer needs and translate these requirements into engineering designs
Optimize design and work collaboratively with other design engineers to optimize design based on test results
Work with external vendors and partners to speed up product development and testing
Create related documentation and support materials in conjunction with design and development activities
Be a hands-on technical resource for mechanical, electrical and software engineering teams by contributing to design ideas, problem solving and leading by example

Qualification

Electromechanical product developmentSystem architecture designPrototype testingReleaseCritical component selectionJAMA (requirements management)Altium (electrical design)SolidWorks (mechanical design)Hands-on capabilityBroad engineering expertiseMedical device experience

Required

Minimum of a B.S. degree in Electrical, Software or related engineering degree
12+ years' experience in electronics design and system design for new product development
Experience working with marketing teams to develop user needs and requirements
Experience developing software driven electromechanical medical devices
Broad engineering expertise across all engineering disciplines
Previous experience with ablation devices is a strong plus
Experience with single use disposable devices
Ability to create clear product design documentation such as concept diagrams, specifications, requirements, test plans, V&V reports
Electromechanical product development
System architecture design
Critical component selection
Prototype, test, and release to production (for single-use disposables and console systems)
Hands-on capability: Candidate must be able to work independently without relying on test engineers or technicians
Minimum Years of Experience: 12+ years
Industry: Strong preference for candidates with medical device experience
Role Level: Senior/Principal

Preferred

Experience with JAMA (requirements management)
Experience with Altium (electrical design)
Experience with SolidWorks (mechanical design)

Company

TekWissen ®

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Welcome TekWissen, your premier partner in technology consulting, workforce solutions, payroll services, procurement, managed services, global capability centers, and venture capital support, specifically tailored for startups in the human capital sector.

H1B Sponsorship

TekWissen ® 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
2025 (5)
2024 (18)
2023 (11)
2022 (9)
2021 (16)
2020 (17)

Funding

Current Stage
Late Stage

Leadership Team

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Rajanish Pandey
Client Partnership Manager
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Company data provided by crunchbase