The Role

DNA Electronics (DNAe) is a dynamic company integrating cutting edge sequencing technologies with novel biochemical techniques to create a revolutionary sample-to-answer sequencing platform. The Product Risk Manager is responsible for overseeing the risk management activities related to products & processes across the whole DNAe organization. They will play a pivotal role in building and maintaining a “Quality culture” in the company in line with DNAe values, standardizing product, and process risk management across the DNAe sites.

Responsibilities

· Plan and coordinate risk management activities in accordance with IVD regulatory standards throughout the product development lifecycle

· Lead and build the risk management strategy and capabilities across DNAe according to relevant international standards and regulatory requirements (i.e., ISO/GxP/FDA)

· Standardize the risk management activities (Hazards Analysis, dFMEA, pFMEA, uFMEA) across the DNAe sites, harmonizing the approach followed by the different teams

· Train, guide and work collaboratively with QA/RA, R&D and Operations teams involved in risk management activities throughout the product development lifecycle, proactively supporting the organization, driving identification, analysis and control of product risks

· Work closely with the Validation Engineering and Supplier Management teams to ensure the downstream processes (Validation and Manufacturing both in-house or outsourced) are aligned with the risk management requirements and that they correctly inform risk monitoring activities

· Provide Quality compliance leadership and consulting expertise to teams with quality/compliance-related questions/concerns and/or those requiring assistance to resolve an historical/ongoing problem regarding risk management activities

· Work closely with the System Integration team to make sure the risk management process is aligned with the hazard analysis and design inputs/outputs related to the DNAe products

· Contribute to the uFMEA working closely with the Commercial team

· Contribute to the QMS by generating or reviewing the SOP’s/WI’s related to Risk Management processes

· Generate and maintain product Risk Management Plans

· Establish and maintain risk management documentation

· Maintain product Risk Management File (RMF)

· Contribute to Regulatory body inspections as a SME for the Risk Management activities

· Accountable to ensure that findings from audits, inspections, and internal reviews related to risk management are translated into positively framed concrete actions to drive improvement

Person Specification

We are looking for people with a passion for their work - people who strive for exceptional results, but who can deliver pragmatic solutions on time. DNA Electronics’ scientists and engineers enjoy and thrive on working in an interdisciplinary team but can also work independently and use their own initiative. The ideal candidate also likes to contribute to solving problems outside their field of immediate expertise and is an effective communicator.

Qualifications

Degree or equivalent in an Engineering, Science or Clinical subjects or at least 7-10 years’ experience in the Medical Device, In-Vitro Diagnostics (IVD) or similar industries in a supervisory role.

· Proven working experience in Quality Risk Management

· Strong knowledge of ISO 14971, ISO 13485 and US FDA 21 CFR Part 820

· An excellent communicator capable of working collaboratively with colleagues in all functions and at all levels

· Ability to communicate technical knowledge in a clear and understandable manner

· Highly collaborative, integrator, strong communicator and influencer holding very good business awareness

· Exceptional verbal, written and organizational skills and the ability to work effectively in a fast-paced, start-up environment

· Creativity and fact-based analytical skills

· Excellent decision-making skills, proficient in providing solutions for complex challenges and good problem-solving using quality tools

· The ability to work independently, show initiative, and be a solid team player

· Experience with establishing statistical techniques and analyzing statistical data using statistical analysis software (e.g., JMP, Minitab, etc.)

Location

DNA Electronics Inc., Carlsbad, CA

Apply

If you believe you meet the above criteria and would relish playing a key role in developing a revolutionary technology, we would be delighted to hear from you.

We offer a competitive compensation package to successful candidates.

For more information about DNAe, please visit our website www.dnae.com

DNAe, Inc. is an equal opportunity employer that does not discriminate on the basis of race, color, national origin, ancestry, religion, sex, gender, age, marital status, physical or mental disability, military or veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by applicable federal, state or local law.

Job Type: Full-time

Pay: $110,000.00 - $160,000.00 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Carlsbad, CA 92008: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Medical Device Regulation and/or In-Vitro Diagnostics: 7 years (Required)
• Quality Risk management: 3 years (Required)
• US FDA 21 CFR Part 820: 5 years (Required)

Work Location: One location

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