| Job Description | Preventice delivers remote monitoring health solutions focused on improving patient engagement, adherence to their care plans, and connections between providers and patients. We combine our expertise in mobile and cloud based technology with world-class clinical and life science partners like the Mayo Clinic.
We are seeking a Sr. Product Development Engineer who will utilize their background in Product Development to lead hardware/product engineering efforts which include: product design, hardware product management, supplier interactions of hardware/product sourcing, and product verification and validation activities associated with medical devices. These devices must meet FDA and CE Mark requirements that ultimately bring high quality, reliable, differentiated and innovative body-worn product components that will enhance and extend the BodyGuardian product line for Preventice.
***This position will report to our SVP of R&D and work in our Rochester, MN office.
Duties: •Provide strategic oversight, program development and leadership direction of the R&D function/department, along with the SVP of R&D, with the goal of achieving the highest product quality.
•Work closely with Product Marketing, QA, operations, select suppliers and finance to define, clarify and focus product requirements for current and new BodyGuardian products.
•Work closely with Product Marketing in combination with customers, focus groups, and clinical study team members to identify and validate product requirements for current and new Body Guardian products. Identify, integrate, and refine technologies and products in close relationship with Product Marketing that can be used to create and enhance the company’s products to satisfy requirements.
•Produce detailed prints, requirements for suppliers and other internal or external designers to model new designs.
•Work with suppliers and manufacturing vendors to select materials, technologies and processes that optimize designs for manufacturability and optimized cost.
•Plan clinical test and evaluation processes that validate and measure usability and performance against the defined requirements.
•Assist senior executives, using organization perspectives and methods, to execute business strategies, improve operations and performance, and optimize roles and responsibilities.
•Strategic Change - assist in the implementation of strategy, business initiatives, and organizational and cultural changes for leadership alignment, change leadership, stakeholder and employee engagement, large scale program design, organization performance, and communications.
•This position may require up to 25% travel including some international travel.
Must have a demonstrated ability to:
•Manage a varied workload to effectively; work on multiple tasks and prioritize work items.
•Use strong written and verbal communication skills to communicate critical design information to project teams and customers.
•Apply technical principles and concepts to product designs.
•Apply FDA, QSR or ISO design control regulations to projects, which result in meeting FDA/ISO company guidelines and policies.
•Use statistical methods, and scientific and engineering principles to analyze and interpret data to make technical decisions on proven data.
•Apply modeling and drafting conventions to product designs.
•Use strong decision making skills to work well independently and as part of a multi-discipline product development team.
Qualifications: Required Qualifications:
•Minimum of a Bachelor's degree in Biomedical Engineering, Material Science, Mechanical Engineering, Chemical Engineering or a related discipline from an accredited university.
•Minimum of 5 years work experience in a medical device company with product design, development, engineering. Manufacturing would be an added value.
•Proficiency with MS Office products.
•Experience or desire to work in a small, demanding, fast paced, and agile company environment.
•Experience working in a team environment.
•Strong oral and written communication skills, including presentation skills.
•Strong management skills.
Preferred Qualifications:
•Experience in electrode, wound care, transdermal drug delivery, or other wearable technologies that require mechanical, electrical, and materials science within product designs.
•Experience with various materials and coating/bonding techniques including plastics, polymers, textiles, hydroelectric gels, hydrocolloids and adhesives.
•Design Control experience working in the development and documentation of regulated products requiring Design History or Technical Files.
•Risk Management experience preferably using the FMEA methodology.
•Demonstrated expertise in mechanical and materials drafting standards preferably using GD&T approaches.
•Experience with multi-component products that include hardware and software components to provide a complete solution for the end user experience.
•Demonstrated background in developing creative solutions to solve design problems.
•Ability to create, review and critically assess patents and other forms of intellectual property. |
| | Company | | Preventice, Inc | Job Code | | State or Province | | Minnesota | | |
|
