Beacon Biosignals

Quality Engineer IV

Beacon Biosignals

full-time

Posted on:

Location Type: Remote

Location: Remote • Massachusetts • 🇺🇸 United States

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Job Level

SeniorLead

About the role

  • SME for hardware and software compliance processes across design, manufacturing, product release, and post market support
  • Leading and providing guidance to the Software, Machine Learning, and Hardware teams for new product development and sustaining engineering to support Beacon goals, collaborating closely with engineering leadership.
  • Improving processes for compliance, implementing the least burdensome approach
  • Representing Beacon in second (customer) and third party audits (ISO auditors) as well as inspections by regulators as the SME in relevant areas.
  • Staying current on changes to international standards and regulations, communicating insights and awareness to broader organization
  • Collaborating and aligning within the quality team and across the company
  • Coordinating product releases in collaboration with Software, Machine Learning, and manufacturing teams
  • Coordinate Product Releases: Collaborate with engineering and machine learning teams to plan, execute, and document product releases.
  • Support Product Development Teams: Provide expertise in the design of regulated products, ensuring compliance with quality standards.
  • Consult Across Teams: Act as a quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control.
  • Ensure Timely Project Delivery: Drive efforts to ensure projects are completed on time, within scope, and in compliance with all regulatory requirements.

Requirements

  • Minimum of 8 years of software experience in a quality environment within the medical device industry
  • Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
  • Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, and ISO 14971
  • Bachelor’s degree in a relevant scientific, engineering, or related field
  • Demonstrated experience implementing IEC 62304
  • A strong intellectual curiosity with the ability to quickly grasp complex concepts, contribute to shaping the quality team, and thrive in a dynamic space.
  • Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders.
  • Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances
  • Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE), preferred but not required
  • Knowledge of European regulatory requirements such as IVDR or MDR, including CE mark process.
Benefits
  • equity
  • PTO
  • other benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
software experienceproblem solvinganalytical skillscompliance processesproduct developmentdesign of regulated productsproject deliveryIEC 62304quality standards
Soft skills
interpersonal skillsrelationship-buildingproject managementguiding decisionsadaptabilityintellectual curiositycommunication skillsorganizational skills
Certifications
Certified Software Quality Engineer (CSQE)Certified Quality Engineer (CQE)