Job Title: Senior R&D Engineer
Type: Contract - 12 Months
Pay: Can Be Flexible
Day Shift
Hybrid worker – but will need to be in the office more than not
Location: 2300 Berkshire Ln N Ste 5, Plymouth, MN
Responsibilities may include the following and other duties may be assigned.
· Understands the requirements of cross-functional internal customers.
· Understanding and wide application of technical principles, theories and concepts in the field.
· Participates in preclinical evaluations.
· Responsible for subset of product design.
· Develops product specs, test methods, equipment. Execute tolerance analysis.
· Creates, reviews and approves protocols/reports.
· Interprets test results.
· Working knowledge of DRM and statistics.
· Responsible for subsystems of designs or smaller designs in their entirety.
· Completes tasks associated with area of responsibility within assigned schedule.
· Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA’s, contributes to assigned sections of submission documents.
· Working knowledge of internal quality system (e.g. SOPs, DOPs), external quality standards, and statistical methods.
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
Review and analyze technical specifications and requirement documents
Modify current design to align to newer product technology/requirements
Translate new requirements to suppliers
Qualify new incoming parts
What products (if any) will this role support? This will be supporting our RPE/Operations effort in the SE Stent VAVE effort (GPX,Everflex and Protégé stent lines)
Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
Nice to Have (Preferred Qualifications)
· Experience with medical device-based products, processes, and technologies
· Medical Device/Pharmaceutical or other regulated industry experience
· Design characterization and design selection experience
· Experience with SolidWorks or AutoCAD
· Proven experience executing product changes regulated by design control, applying product development process to derivative product line
· Mechanical design experience - modeling for devices and fixtures
· Prototyping of devices and fixtures through 3d printing and/or machining; catheter device experience
· Device design verification testing and test development
Can you please confirm your top 3 skills sets required?
Analysis of technical specifications and requirements.
Design modification – translations into/ to specifications/requirements
Testing/qualification of new components
What is your target years of experience? 5-7 years - need someone that is independent and has enough experience
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
