and therapies for the treatment of stroke related diseases.
A Day in the Life
The Senior R&D Engineer is a technical contributor to the Research & 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. This role will provide technical leadership, deep subject matter expertise, technical/project oversight, and team member training/coaching.
ESSENTIAL FUNCTIONS
Evaluate and implement design, material, supplier, manufacturing, and labeling changes for released products while ensuring compliance with design control, risk management, and regulatory requirements.
Author, review, and approve engineering documentation including design specifications, risk analyses, test methods, protocols, reports, engineering change orders, and technical assessments.
Provide technical leadership for commercialized products, including design improvements, obsolescence mitigation, cost-reduction initiatives, and supply continuity projects.
Lead investigations and engineering rationale related to product nonconformances, complaints, CAPAs, field issues, manufacturing issues, and supplier quality concerns using structured problem-solving methodologies.
Create protocols, perform data analysis, and author reports to demonstrate that product and process changes meet design intent and regulatory requirements.
Collaborate with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations teams to evaluate product performance and implement effective solutions.
Assess supplier changes, manufacturing process changes, equipment qualifications, and material modifications to ensure continued product quality and performance
TECHNICAL SPECIALIST CAREER STREAM
An individual contributor with responsibility in our technical functions to sustain or advance existing technology. Formulates, 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 R&D, systems or initiatives related to existing or new technologies/therapies, while adhering to policies, using specialized knowledge and skills.
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 in-depth 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 decision-making.
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 a Baccalaureate degree and minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
