Senior Product Compliance Engineer

Element Biosciences•San Diego, CA

2d•$102,000 - $130,000•Onsite

About The Position

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. We are seeking an experienced Senior Product Compliance Engineer 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. If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Requirements

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
Experience with design, testing and compliance management with EMC, Safety, and RF requirements
Experience communicating and working with certification bodies and test labs
Understands Engineering and Operations issues as they relate to product compliance
Ability to explain and document regulatory and standards requirements and constructively critique product documentation written by teammates
Demonstrate strong and effective verbal, written, and interpersonal communication skills
Strong interpersonal skills with the ability to collaborate closely with Engineering and Operations staff of varying levels to deliver necessary compliance requirements
Demonstrates an ability to work independently and as part of a team
Demonstrate ability to effectively collaborate with others to achieve team goals and expectations
Self-motivated and able to organize and prioritize multiple tasks
Ability to work in a fast-paced and technically challenging environment where drive is critical to success

Nice To Haves

Project management certification, PMI PMP, is a plus

Responsibilities

Partner with Engineering and Operations to deliver best-in-class products
Interpret regulatory/product compliance requirements and provide input to NPD, Sales/Product Management, and Factory on product additive changes
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
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)
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
Identify compliance related risks, effectively communicate the threat and suggest best means for avoiding or reducing the risk
Obtain and maintain product regulatory certifications required to support commercialization of products by collaborating with the factory and applicable stakeholders
Provide compliance direction and take the lead on regulatory input during the product design process
Independently determine a general approach and specific solutions to compliance problems and offer process improvements
Plan and support third-party audits and internal audits, as needed
Engage with NRTLs to drive compliance programs, as needed