Compliance Engineer

  • Stealth Mode Startup Biotech
  • Newark, CA, USA
  • Jan 07, 2022
Full time Biotech

Job Description

High growth, pre-IPO company in stealth mode

Join a rapidly growing company that is developing ground-breaking genomics technologies that will push the boundaries in the clinical, life sciences research and therapeutic fields. We are well-funded by global top-tier investors, including venture capital firms and growth equity investors. Our team brings together unique and diverse expertise across multiple disciplines, from healthcare and life sciences, to engineering, to technology and software and beyond.  We are a collaborative group of more than 200 employees, including successful entrepreneurs, hardware and software engineers, genomics and biotechnology experts, molecular and computational biologists, software and algorithm experts, and operations and commercial leaders. Play an important role in the development and commercialization of technology and products that will accelerate our understanding of life, biology and disease and transform large industries.

We are looking for a highly motivated Compliance Engineer to join our team!

You will be responsible for supporting design effort regarding regulatory compliance of cutting-edge technologies pushing the interpretations of existing standards and requirements. Areas of compliance would include but would not be limited to, both domestic and international Product Safety, EMC and Laser Safety Standards. This is an opportunity to shape the compliance vision for the company and play a pivotal role in addressing worldwide market access.

How You’ll Contribute

  • Work with outside consultants on compliance and regulatory issues
  • Interface with regulatory agencies.
  • Prevents compliance issues by collaborating with engineering teams, identifying and resolving design issues and developing compliance policies.
  • Qualify vendors, components, and parts
  • Documents compliance by completing approval applications; recording test results; preparing investigative reports; preparing and filing Declarations of Conformity; maintaining compliance database.
  • Submit reporting packages to agencies

Qualifications, Skills, Knowledge & Abilities

  • Bachelor’s degree in Engineering or related field.
  • Extremely motivated and willing to work in a fast-paced environment as part of a hard-working and multidisciplinary team.
  • Organization, verbal communication, attention to detail.
  • CAD experience, preferably SolidWorks.
  • Experience with EU directives, LVD 2014/35/EU, EMC 2014/30/EU, Machinery 2006/42/EC, and RoHS3 2015/863/EU.
  • Knowledge of the following standards: UL61010, CAN/CSA-C22.2 NO. 61010, IEC 61010-1, IEC 61010-2-120, IEC 61010-2-081; IEC 61010-2-010, EN60825-1, EN62368-1, FCC 47 CFR Part 15, Subpart B, ANSI C63.4 (2009); ICES-003 Issue 6; CISPR 32.

When applying, please note that you saw the job posted on the NOVAworks Job Board. If you need help with your resumé, please see a NOVAworks Career Advisor.