Senior Process Development Engineer (Plymouth, MN, US) presso None

Position Summary

This position's responsibility is for managing and developing new products, while interfacing customers, vendors, and internal departments to achieve the desired product specification. The goal is to develop products, define specifications to establish reasonable timelines while developing high quality products that meet the end user’s expectations. 

Principal Responsibilities

The Senior R&D Engineer is responsible for, managing quick turn medical device OEM projects, responding to Requests for Quotes, and prototyping catheters and balloon sub-assemblies. Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high quality products. This position is ideally suited for experienced Engineers that like to roll up their sleeves and spend time on the production floor, enjoy autonomy, and quick results from their efforts. 

•    Hands-on catheter/balloon design, development, and assembly experience 
•    Accurately predict project costs, material lead times, and delivery schedules during quoting process.
•    Develop bills of materials and assembly method, and provide training to technicians and assemblers.
•    Will work with many areas including: complex catheters, steerables, smart catheters, balloons, handle design, molding, braiding, tipping, coating, extruding.
•    Develop balloons (including extrusion design) and catheter subassemblies according to customer design, performance, and quality specifications; on time and within budget.
•    Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
•    Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
•    Review and prepare status reports, modify schedules, and project plans as required
•    Keeps stakeholders, customers, and others informed of project status and/or related issues
•    Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
•    Apply design controls from initial customer requests throughout the products life cycle
•    Intimately involved in developing technical documentation: protocols, including verification and validation testing, drawings, calculation and/or FMEA
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
•    Address customer's issues: improve performance, appearance, and impact on end-user

Education / Experience Requirements

•    Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering required
•    Master's degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
•    Proven balloon development experience 
•    5 years' or more experience in Medical Device development or manufacturing

Specialized Skills / Other Requirements

•    Working knowledge of manufacturing processes related to medical device manufacturing
•    Ability to prioritize and work independently as a self-starter with strong proactive work ethics
•    Experience with design controls, FDA regulation, GMP practices, and QSR requirements
•    Proficient in Microsoft Office, Project, Minitab, and Solidworks preferred
•    Experience with Risk Analyst tools and procedures
•    Proven track record in Leadership role and utilizing Project Management
•    Proven track record in product development, design, and working closely with manufacturing
•    Demonstrated customer relations, problem solving, and product development skills
•    Ability to influence across boundaries, drive collaboration, and develop product to meet expectations
•    Must be well-organized, detail-oriented, with excellent oral and written communication skills

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($109,300-164,000)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.