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Sr Biomedical Engineer
3 months ago
Job Description:
We are seeking a Sr Biomedical Engineer for a very important client.1.To hit monthly document approval goals: 1 Initiative meetings/conversations/collaboration with Neuro Standards Team (5 with 1 in India) and SMEs [sterilization, packaging, labeling, radio regulatory, risk, released products (SW/EE)] 2 Working with this team, Create and gain approved of documents.1 What products (if any) will this role support? All of Neuromodulation/Pelvic Health Release Products (External devices, Stimulators, Pumps, catheters/leads/accessories) Responsibilities may include the following and other duties may be assigned Create standard/regulation documentation to show gaps, plans, and final completion evidence Initiate and drive cross-functional meetings to align with SMEs (sterilization, packaging, labeling, radio regulatory, risk, released products (SW/EE) and Project team Outcome of alignment is ability to author and execute documentation approval to achieve project monthly goals. Responsibilities may include the following and other duties may be assigned Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays 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).
Requirement:
The ideal candidate will possess the following qualifications: 1.Medical device robust documentation for audits (Communication written and verbal), Team Work/collaboration, Drive/Initiative to hit goals 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 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.
