Sr R/D Engineer - Exempt

Must Have:
1. Investigation and root cause analysis skills 2. Technical writing knowledge. Organization and Communication skills 3. Process validation knowledge close
2 years Medical Device experience
6. Project management experience
Bachelors Degree > Bachelors Degree Engineering

Nice to Have:

Masters Degree > Masters Degree Engineering
MEDICAL DEVICE DESIGN EXPERIENCE

HM's Top Needs:
1. Medical Device Experience
2. Effective communication and problem-solving skills
3. Project management experience

Here's a brief version of JD I recently used for full-time Sr Engineer:
The Senior R&D Engineer is a technical contributor to the Released Product Engineering team. This role is responsible for ensuring that NV medical devices comply to corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.
Lead and provide guidance in work involving verification/validation and product specifications, including material specifications, assembly drawings and other documentation
Create test protocols using appropriate statistical rationale for design studies, benchtop testing, and verification/validation testing
Participate in risk analysis and risk management activities in a multidisciplinary team environment
Provide R&D engineering direction and support for existing products
Technical leadership with cross-functional teams of large scope and complex projects
Works with senior leadership/management, cross-functional key stakeholders, and team to deliver project deliverables on time
Education Required: BS Engineering, MS Engineering
Years' Experience Required: 4+ years with BS or 2+ years with advanced degree
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Work Location:
Do they need to be local to any MDT office and if so where? Irvine-UCI Bldg
Does this person need to be on site? If so, full time or part time? Onsite, Flex (3+ days/week)

Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during product sustaining activities. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and validations. 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 . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. Should 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.