Element Biosciences is a San Diego-based multi-disciplinary life science company that develops advanced DNA sequencing and multi-omics technologies.
<p>At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.</p> <p>We are seeking an experienced <strong>Senior Product Compliance Engineer</strong> who will be responsible for providing compliance leadership and project management to ensure EMC, safety, and RF compliance throughout the product development and lifecycle processes. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our goals and lead projects with Engineering teams. This role will report to the Director, Quality & Regulatory and will be an onsite, San Diego based role.</p> <p>If you possess the following and want to make a meaningful impact, we invite you to explore this role.</p> <p><strong>Essential Functions and Responsibilities:</strong></p> <ul> <li>Partner with Engineering and Operations to deliver best-in-class products</li> <li>Interpret regulatory/product compliance requirements and provide input to NPD, Sales/Product Management, and Factory on product additive changes</li> <li>Monitor and analyze changes in regulations and standards for U.S., Canada, and EU that may impact the organization’s product compliance programs, with a strong focus on EMC and Radio Frequency (e.g., FCC), and support for Product Safety (e.g., IEC, UL, CSA) requirements</li> <li>Develop and implement project planning and execution while proactively engaging internal and external stakeholders to achieve desired targets and goals (identifying critical milestones, gating items and priorities, determining deadlines for deliverables on critical path, and communicating to Engineering team members)</li> <li>Oversee the coordination of EMC and Safety evaluation with Factory, Engineering, and Third-party testing partners to ensure products comply with all regulations and industry standards</li> <li>Identify compliance related risks, effectively communicate the threat and suggest best means for avoiding or reducing the risk</li> <li>Obtain and maintain product regulatory certifications required to support commercialization of products by collaborating with the factory and applicable stakeholders</li> <li>Provide compliance direction and take the lead on regulatory input during the product design process</li> <li>Independently determine a general approach and specific solutions to compliance problems and offer process improvements</li> <li>Plan and support third-party audits and internal audits, as needed</li> <li>Engage with NRTLs to drive compliance programs, as needed</li> </ul> <p><strong>Education and Experience:</strong></p> <ul> <li>Bachelor’s Degree in Electrical Engineering, Computer Engineering or related field AND a minimum of 5 years relevant experience OR an equivalent combination of education and experience</li> <li>Experience with design, testing and compliance management with EMC, Safety, and RF requirements</li> <li>Experience communicating and working with certification bodies and test labs</li> <li>Understands Engineering and Operations issues as they relate to product compliance</li> <li>Ability to explain and document regulatory and standards requirements and constructively critique product documentation written by teammates</li> <li>Demonstrate strong and effective verbal, written, and interpersonal communication skills</li> <li>Strong interpersonal skills with the ability to collaborate closely with Engineering and Operations staff of varying levels to deliver necessary compliance requirements</li> <li>Project management certification, PMI PMP, is a plus</li> <li>Demonstrates an ability to work independently and as part of a team</li> <li>Demonstrate ability to effectively collaborate with others to achieve team goals and expectations</li> <li>Self-motivated and able to organize and prioritize multiple tasks</li> <li>Ability to work in a fast-paced and technically challenging environment where drive is critical to success</li> </ul> <p><strong>Physical Requirements: </strong></p> <ul> <li>Frequently moves boxes weighing up to 20 pounds</li> </ul> <p><strong>Location: </strong></p> <ul> <li>San Diego, CA (on-site)</li> </ul> <p><strong>Travel: </strong></p> <ul> <li>Domestic travel up to 10%</li> </ul> <p><strong>Job Type:</strong></p> <ul> <li>Full-time/Exempt</li> </ul> <p><strong> </strong><strong>Base Compensation Pay Range:</strong></p> <ul> <li>$102,000 - $130,000</li> </ul> <p><em> </em></p> <p><em>In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off. </em></p> <p><em>Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. </em></p> <p> </p> <p>We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.</p>