Senior R&D Engineer

Tactile Medical•New Brighton, MN

About The Position

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Sr Research and Development Engineer is responsible for leading technology and product development efforts as a core member of the Product Development team and executing necessary engineering deliverables to ensure the Product Development goals and objectives are met. They influence decision-making at all levels of the product development life cycle and will maintain technical ownership of design-related project deliverables from concept through design transfer. This person actively collaborates with functions throughout Tactile Medical and leverages cross-functional partnerships to drive product and technology roadmap development. As a product SME and technical leader, drive project objectives with minimal oversight ensuring project milestone progression is clearly communicated and understood by cross-functional partners. Create and test prototypes for design concepts that may apply to projects 1-5 years out. This includes mechanical and electrical components prototyping using additive manufacturing techniques and other quick-turn methods. Preferably able to execute low level programming to incorporate electrical system functionality into prototypes. Identify, investigate, and test feasibility of new technologies for application to future projects. Execute the technology development roadmap which is tied to the long-term goals of Tactile Medical. Lead cross-functional efforts with marketing, clinical, and regulatory to drive next-steps of concepts. Manage the overall technical scope of a product development effort including translating product requirements into product specifications, product design, verification and validation plans, product cost and technical schedule. Ensure all engineering deliverables outlined in the Design and Development Procedure are accurate and completed on time. Drive completion of design input requirements through partnership with cross-functional stakeholders. Ownership of engineering efforts to translate design input requirements into product specifications. Throughout the product development lifecycle, ensure the needs of supply chain are met when determining existing and new supplier’s capabilities. Manage and/or execute R&D engineering deliverables to maintain overall project schedule, with an emphasis on technical tasks and deliverables. Contribute to creation of risk management documentation related to design risks and hazards. Develop and maintain engineering documentation (drawings, specifications, bills of materials, etc.) and ensure quality, completeness, accuracy, and timeliness to support project requirements. Ensure product design complies with relevant regulatory/IEC standards. Prepare and present product development presentations for senior management. Support manufacturing’s performance in meeting quality, productivity, and delivery objectives. Communicate events and project updates effectively to core team members in written and verbal formats. Troubleshoot new and existing products/process problems as related to design, material, or processes. Ensure process and procedures adhere to internal and external requirements. Participate in Design Transfer to Manufacturing. Other duties as assigned.

Requirements

Bachelor's Degree in Mechanical Engineering, Electrical Engineering or similar field required
6+ years of engineering experience, preferably within medical device products OR Master’s Degree in Engineering or similar field with 4+ years of engineering experience, preferably within medical device products
Influence without authority, develop strong relationships cross-functionally and collaborate through conflict to accomplish project goals under tight deadlines
Strong prioritization and reprioritization skills
Demonstrated problem solving skills and analytical abilities
Easily adapts to changing business needs and adept at juggling numerous projects and deadlines
High proficiency in Microsoft Word, PowerPoint, and Excel
Results-oriented and naturally focuses efforts on innovative and cost-effective solutions
Excellent written/verbal communication and presentation skills to clearly articulate concepts, status, and challenges to a broad range of audiences
Operate as a strong team player with a high degree of flexibility
Facilitate meetings of varying sizes, balancing the needs, voices, and concerns of all participants
Electrical, mechanical prototyping
Ability to interpret electrical and mechanical schematics
Basic understanding of lean principles and processes
Curious and questioning mindset which can be applied in new development as well as towards continuous improvement
Draw from diverse experiences applying engineering knowledge to different situations
Ability to collaborate with both technical and non-technical team members

Nice To Haves

Experience in leading medical device technical development efforts, through all phases of product development
Experience utilizing a stage / phase gate process within the medical device industry
Experience using SolidWorks, AutoCAD, or other CAD modeling software
Experience in digital signal processing
Able to execute low level programming to incorporate electrical system functionality into prototypes

Responsibilities

Lead technology and product development efforts as a core member of the Product Development team.
Execute necessary engineering deliverables to ensure Product Development goals and objectives are met.
Maintain technical ownership of design-related project deliverables from concept through design transfer.
Actively collaborate with functions throughout Tactile Medical and leverage cross-functional partnerships to drive product and technology roadmap development.
Drive project objectives with minimal oversight ensuring project milestone progression is clearly communicated and understood by cross-functional partners.
Create and test prototypes for design concepts that may apply to projects 1-5 years out, using additive manufacturing techniques and other quick-turn methods.
Identify, investigate, and test feasibility of new technologies for application to future projects.
Execute the technology development roadmap which is tied to the long-term goals of Tactile Medical.
Lead cross-functional efforts with marketing, clinical, and regulatory to drive next-steps of concepts.
Manage the overall technical scope of a product development effort including translating product requirements into product specifications, product design, verification and validation plans, product cost and technical schedule.
Ensure all engineering deliverables outlined in the Design and Development Procedure are accurate and completed on time.
Drive completion of design input requirements through partnership with cross-functional stakeholders.
Own engineering efforts to translate design input requirements into product specifications.
Ensure the needs of supply chain are met when determining existing and new supplier’s capabilities throughout the product development lifecycle.
Manage and/or execute R&D engineering deliverables to maintain overall project schedule, with an emphasis on technical tasks and deliverables.
Contribute to creation of risk management documentation related to design risks and hazards.
Develop and maintain engineering documentation (drawings, specifications, bills of materials, etc.) and ensure quality, completeness, accuracy, and timeliness to support project requirements.
Ensure product design complies with relevant regulatory/IEC standards.
Prepare and present product development presentations for senior management.
Support manufacturing’s performance in meeting quality, productivity, and delivery objectives.
Communicate events and project updates effectively to core team members in written and verbal formats.
Troubleshoot new and existing products/process problems as related to design, material, or processes.
Ensure process and procedures adhere to internal and external requirements.
Participate in Design Transfer to Manufacturing.