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Sr Engineer - Risk Management-Remote (JP8009)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Sr Engineer - Risk Management-Remote (JP8009)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date:14 December 2020
Note: Remote- must work within PST hours
3 Key Consulting is hiring a Sr Engineer - Risk Management-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Candidate must have experience working within regulated industry (see below)
  • Candidate may be fully remote - must work within PST hours.
  • The client is currently seeking a Sr. Engineer in our Final Products and Technology Risk Management (FPT-RM) team. In support of the client’s mission to serve patients, the FPT-RM team at the client is a diverse team working to develop and continuously improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience.
  • The Sr. Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMF) for the client’s portfolio of combination products, as well as serving as Risk Management lead on assigned projects.
  • The Sr. Engineer will leverage leadership skills to actively engage with multi-functional groups to support the RMF, as well as support cross functional processes interfacing with Risk Management. This includes interfacing with the complaints and safety teams to support life cycle management.
  • The Sr. Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing FPT-RM in corresponding audits. Responsibilities will also include the continued advancement of risk assessment processes, methods and tools, and business processes for ongoing continuous improvement.
  • Ensures Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971 for all the client n commercialized combination products.
  • Creates and maintains the RMF’s.
  • Conducts risk assessments and creates/revises risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.
  • Management of hazard analyses, design risk assessments, use risk assessments, system risk assessments, and process risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.
  • Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures.
  • Leads periodic and event driven risk reviews of the RMF’s for commercialized products.
  • Supports the complaints intake teams with assessment of risks related to reported complaints.
  • Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements.
  • Successfully influences outcomes, communicates with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting.
  • Understands manufacturing processes for the client’s packaged and/or distributed products.
  • Supports root cause analysis of complaint investigations.

Basic Qualifications:
  • Doctorate degree; OR
  • Master’s degree and 3 years of risk management or engineering experience; OR
  • Bachelor’s degree and 5 years of risk management or engineering experience; OR
  • Associate degree and 10 years of risk management or engineering experience; OR
  • High School diploma/GED and 12 years of risk management or engineering experience

Preferred Qualifications
  • Bachelor’s or master’s degree in Engineering, preferred Mechanical Engineering, Electrical Engineering, Systems Engineering, Materials Engineering, or Bio-Medical Engineering.
  • 6 or more years of experience with risk analysis methods such as PrHA and FMEA for medical devices.
  • 5 or more years of experience in a Medical Device Development or Device Risk Management role.
  • 3 or more years of experience with Medical Device Reporting requirements, preferably for the European Union.
  • Experience with risk management per ISO 14971.
  • Experience is leadership role(s) and working with cross functional groups.
  • Experience working with complaints intake and complaints investigation teams.
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to converse technically with mechanical, electronic, software, and quality engineers.
  • Capable of managing multiple projects in a deadline driven environment.
  • Strong technical writing and interpersonal skills.
Top Must have Skill Sets:
  • Experience with risk management per ISO 14971
  • Ability to converse technically with mechanical, electronic, software, and quality engineers
  • Capable of managing multiple projects in a deadline driven environment
Employee Value Proposition:
Exposure to a broad set of products, skills, great learning environment, leadership.
Red Flags:
No experience within regulated environment.
Interview Process:
Pre-Screen interview with Edward Nielsen
Panel interview with TBD staff 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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