Senior Engineer, Electrical, Medical Device - Remote (JP9383)
Thousand Oaks, Ca · Biotech/Pharmaceutical
Job Title: Senior Engineer, Electrical, Medical Device - Remote (JP9383) Location: Thousand Oaks, CA. (Remote) Employment Type: Contract Business Unit: Systems Engineering and Combination Product Risk Management Duration: 12 months with likely extensions or conversion to FTE Posting Date: 10/28/2021
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: We are seeking a Sr. Engineer in our client’s Final Products and Technology Risk Management (FPT-RM) team. In support of company’s mission to serve patients, the FPT-RM 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 company’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 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 company’s packaged and/or distributed products
Supports root cause analysis of complaint investigations
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’s degree and 10 years of risk management or engineering experience; OR
High School diploma/GED and 12 years of risk management or engineering experience
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
The team strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients. And every step of the way, we are guided by the values that define us.
Why is the Position Open? Supplement additional workload on team.
Top Must-Have Skill Sets:
ISO 14971 required
Risk Management Experience
Regulated Industry Experience (Medical, Aerospace, Defense, etc.)
Good communication skills
Day to Day Responsibilities:
Work on process improvement initiatives
Work on maintaining and developing risk management files
Masters/Bachelors 5+years OR Doctorate 3+ years of System Engineering experience in Drug Delivery or Aerospace.
Strong systems engineering experience in pharma preferred or systems engineering in medical devices or systems engineering in Aerospace.
Prefers the candidate to have experience in drug delivery devices.
Prefers the candidate to have experience in requirements management tool such as DOORS.
Employee Value Proposition: The person in this role will work on process improvement activities, updating risk management files, maintain risk management products from start to finish, and developing risk management files for new products Red Flags: Excessive job jumping beyond typical Less than really good communication skills, verbal and written Interview process: Phone pre-screen viable candidates. After pre-screen, panel interview We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.