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Predicine · 1 month ago

Medical Device Design Control Engineer

Hayward, CA

Full-time

Onsite

Senior Level

5+ years exp

Predicine, Inc is seeking an experienced Medical Device Design Control and Risk Management Contractor to support quality, regulatory, and product development initiatives in the molecular diagnostics space. The role involves collaborating with cross-functional teams to ensure compliance with regulatory, quality, and performance standards for NGS-based products and workflows.

BiotechnologyHealth DiagnosticsLife Science

H1B Sponsor Likely

Responsibilities

Develop, maintain, and optimize design control documentation including User Needs, Design Inputs, Design Outputs, Verification/Validation plans, and Design History Files (DHF) for NGS-based products or assays

Support Design Reviews and design transfer activities for NGS workflows and instrumentation

Establish traceability matrices linking requirements, risks, sequencing workflow steps, and V&V activities

Lead and facilitate risk management activities per ISO 14971, including hazard analyses, FMEAs (DFMEA, PFMEA), and risk control strategy development

Maintain and update Risk Management Files (RMF) throughout product lifecycle

Provide subject-matter expertise in risk evaluation, benefit–risk analysis, and post-market risk assessment

Ensure alignment of design and development processes with GMP, QSR, and ISO 13485 requirements

Review and improve SOPs, work instructions, and product documentation to strengthen compliance

Conduct gap assessments and recommend corrective/preventive actions (CAPA) for design or process-related issues

Support audits (internal/external), including preparation of evidence and remediation activities

Work closely with R&D, Quality Assurance, Regulatory Affairs, and Operations to ensure smooth development pathways

Provide training or guidance on design control and risk management best practices

Qualification

Design controlsRisk managementGMPISO 13485Next Generation SequencingISO 14971Regulatory frameworksAnalytical skillsSoftware tools proficiencyDocumentation skillsCommunication skillsCross-functional coordination

Required

Bachelor's or Master's degree in Molecular Biology, Biomedical Engineering, Genetics, or related field

5+ years of industry experience, including hands-on experience in NGS testing, sequencing workflow development, or molecular diagnostics

Proven expertise in design controls, risk management, ISO 14971, GMP, ISO 13485, and FDA regulatory frameworks

Experience with Illumina, ThermoFisher, or other NGS platforms; knowledge of bioinformatics workflows is a plus

Familiarity with oncology, liquid biopsy, ctDNA, or other clinical sequencing applications (preferred)

Strong documentation, communication, and cross-functional coordination skills

Preferred

Advanced degree or certification in Quality Assurance, Regulatory Affairs, or a related discipline

Experience with risk management standards such as ISO 14971

Familiarity with software tools used for design control documentation and project management

Previous experience working in a research and development or automation environment within the medical device industry

Demonstrated ability to lead design control audits and regulatory inspections

Company

Predicine

Predicine is a molecular information company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring.

Founded in 2015

Hayward, California, USA

51-200 employees

http://www.predicine.com/

H1B Sponsorship

Predicine has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (4)

2024 (4)

2023 (4)

2022 (4)

2021 (3)

2020 (2)