Staff R&D Engineer in Remote

The Urology and Critical Care (UCC) business unit is seeking a Staff Engineer for the Research and Development group. The position is responsible for the design and development of innovative products within the Home Care Platform, which is high-growth platform in UCC.

This role will partner with Platform Marketing teams to interface with cross-functional internal and external experts, key opinion leaders, and customers to gather feedback, identify, assess, and build support for innovation business cases that expand the Home Care portfolio and delivery new solutions to customer and patients worldwide.

Provides Technical Leadership for New Product Development projects, Sustaining and Early-stage ideation projects. The ideal candidate will have experience working with Class 1, 2 & 3 electro-mechanical medical devices.

SUMMARY:

The Urology and Critical Care (UCC) business unit is seeking a Staff Engineer for the Research and Development group. The position is responsible for the design and development of innovative products within the Home Care Platform, which is high-growth platform in UCC.

This role will partner with Platform Marketing teams to interface with cross-functional internal and external experts, key opinion leaders, and customers to gather feedback, identify, assess, and build support for innovation business cases that expand the Home Care portfolio and delivery new solutions to customer and patients worldwide.

Provides Technical Leadership for New Product Development projects, Sustaining and Early-stage ideation projects. The ideal candidate will have experience working with Class 1, 2 & 3 electro-mechanical medical devices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provides Technical Leadership for New Product Development projects, Sustaining and Early-stage ideation projects.

Directly responsible for leading urgent and/or important projects from the planning and administration of the product through all development, laboratory test, clinical evaluation, and market preference test.

Invent/Innovate prototype devices utilizing innovative material and process technologies to achieve concept objectives. Conduct design reviews and perform failure mode and effects analysis.

Be able to work independently applying comprehensive and diverse engineering principles and practices to broad assignments, possibly including independently leading a moderate project, under the direction of Technical Management.

Review new product concepts; and in conjunction with a product development team, develop performance specification and project schedules.

Creation of 3-D CAD databases.

Closely follow established design control procedures and documentation practices.

Assist in ensuring the Quality System Requirement (QSR) compliance of design control process in product development

Develop laboratory tests, protocols and reports to assure conformance of prototype devices to performance specifications, FDA and applicable international regulatory and biocompatibility requirements.

Interface with internal and external engineering groups for the fabrication of devices to support both animal and human clinical evaluation

Evaluate device performance through animal and/or human clinical investigation; and, as required, implement appropriate product changes to include revision of performance specifications.

Transfer new products/systems to Manufacturing

Interface with vendors, consultants, and customers. Provide guidance on the development of supply agreements as required.

Provide technical direction to manufacturing during pilot production, as well as on currently manufactured products.

Communicate project status, through verbal and written reports and schedules, to management.

QUALIFICATIONS:

Proven experience in technology or innovative product development preferably in the medical device industry with successful track record of commercializing Class 1, 2, products

Prefer knowledge of Mechanical, Plastics, Chemical or Biomedical Engineering normally attained through a minimum of a 4-year technical degree. Advanced degree in business or equivalent experience is needed.

MS, MBA or PhD preferred

Experience in Urology, Surgical, Wound Care preferred.

Proven ability to interface with various levels of the organization.

Requires solid understanding of:

Industry regulations as it pertains to medical devices

External Standards, Design controls, Quality controls, Manufacturing methods

Requires track record of:

Development and commercialization of medical devices

Generating and documenting intellectual property

In depth or creative approach to problem solving

Contributes to development of new concepts

Technical guidance on design theories and applications

Capable of prioritizing tasks and provide a timely schedule of completion.

Capable of detailed component and sub-assembly level analysis (not limited to tolerance or finite element analysis)

Capable of performing complex analysis independently

Demonstrated proficiencies of communicating best practices

Protocol/report testing and writing

EDUCATION and/or EXPERIENCE:

8-10+ years of experience as a design / development engineer.

Minimum of a 4-year technical degree in Mechanical Engineering.

Creativity in new product concepts, designs and manufacturing processes.

Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget.

COMPUTER SKILLS:

Full working knowledge of Microsoft Office Suite programs and various statistical software packages.

Good Internet skills, including ability to perform searches for specific information and all information on a specific topic, etc.

LANGUAGE SKILLS:

Good oral and written communication.

Ability to read, analyze, and interpret professional/technical journals, scientific literature, procedures, and governmental regulations.

Ability to write routine reports and business correspondence.

Ability to communicate well with individuals at all levels of the organization.

MATHEMATICAL SKILLS:

Ability to perform basic engineering calculations.

Well versed in design of experiments.

Understanding of statistical concepts.

REASONING ABILITY:

Ability to solve practical problems and deal with a variety of concrete variables where only limited standardization exists.

This position requires good judgment. All activities are to be carried out according to applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources.

Base Salary - $120,000 to $120,000

5+ to 7 years experience

Seniority Level - Mid-Senior

Minimum Education - Bachelor's Degree

Willingness to Travel – Occasionally