Principal Systems Engineer/Sr. Systems Engineer
Adela
Adela’s mission is to deliver innovative and accessible blood tests that harness biology to transform cancer care and improve well-being. The company is developing best-in-class technology to accelerate the diagnosis and improve the management of cancer through blood tests for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Adela’s blood-based, tissue-free product ensures universal accessibility to MRD testing for patients with cancer, eliminating any dependency on tumor tissue availability. Adela’s first product was recently clinically validated for predicting and surveilling for recurrence in patients with head & neck cancer and published in Annals of Oncology.
Adela is seeking a Principal Systems Engineer/Sr. Systems Engineer will lead platform validation and systems integration activities across software, lab operations, assay development, regulatory, and quality functions. This role will directly track requirements traceability, perform documentation stewardship, and and assist in bringing the system aligned with business processes. The role includes primary responsibility day-to-day and release-to-release management of baselines and requirements in Jama Connect. This remote position is open to candidates authorized to work in the U.S. or Canada. No visa sponsorship is available.
Essential Duties and Responsibilities
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Help build the requirements framework (ISO 15288 aligned): stakeholder → system → software; configure Jama templates, workflows, baselines, and reviews based on framework.
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Collaborate with stakeholders on design control deliverables and the DHF: V&V plan/protocols/reports, RTM, release baselines, approvals.
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Help author, maintain, and lifecycle control the engineering SOPs, WIs, and associated documentation standards.
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Creation and traceability of system requirements and stakeholder requirements
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Execute validation activities related to commercial readiness, including platform re-validation and iterative software releases under CAP/CLIA.
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Track requirements coverage and help ensure traceability is maintained across releases, validation cycles, and regulatory submissions.
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Manage and document change control activities in partnership with Quality for CAP-regulated software updates
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Model business processes (BPMN); apply MBSE/SysML-lite where pragmatic to align lab, assay, customer service and software flows.
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Partner with stakeholders and Quality to execute safety risk management activities, including FMEA, hazard analysis, risk acceptability criteria, and linkage to verification within established Quality risk management procedures.
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Coordinate the transfer of technical documentation and SOPs from R&D through production readiness
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Support integration of third-party partner deliverables into requirements and validation framework
Work Experience & Skill Requirements
- Bachelor’s degree in engineering, life sciences, computer science, or a related technical field
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Training or coursework in systems engineering, software development, or quality systems preferred
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5+ years experience (Sr. Systems Engineer) and 7+ years (Principal) of experience in systems engineering, validation, or technical program management in a regulated or structured environment (e.g., aerospace, automotive, diagnostics, medical device)
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Demonstrated experience writing and managing multi-tier requirements under a formal framework (e.g., ISO 15288, DO-178, ISO 26262, IEC 62304)
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Familiarity with software development, lab operations, or lab automation
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Hands-on experience with requirements management tools (e.g., Jama, DOORS, Helix RM, etc.): templates, workflows, review center, baselines.
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Experience modeling business processes using BPMN or equivalent methods
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Strong technical writing skills and ability to coordinate documentation across functions
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Experience with iterative software release cycles and change control in regulated environments (e.g., CAP/CLIA)
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Excellent verbal and written communication skills
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Excellent computer proficiency (e.g., MS Office, Google Workspace)
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Ability to work independently and lead cross-functional initiatives with minimal oversight
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Ability to work under pressure and meet deadlines while maintaining a positive, collaborative attitude
Preferred Qualifications:
- Experience in IVD, biotech, or diagnostics environments
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Familiarity with CAP/CLIA or similar regulatory frameworks
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MBSE/SysML experience
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Experience with BPMN tools such as Signavio, Lucidchart, or Camunda
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Prior mentorship or management experience with technical staff
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Experience mapping validation deliverables to business process workflows
The annual base salary range for this position $140,000 to $165,000 USD (Sr. Systems Engineer) and $160,000 to $180,000 USD (Principal Systems Engineer) level. This range reflects only the base salary component of compensation and is provided in compliance with applicable pay transparency requirements. Actual base salary will be determined at the Company’s discretion and may vary based on a number of factors, including but not limited to geographic location, relevant experience, skills, qualifications, internal equity, and business needs.
Adela is committed to fostering diversity and inclusion in our workplace. We embrace and celebrate the unique qualities and perspectives of all individuals, and we provide equal employment opportunities to candidates without regard to race, color, ancestry, national origin, religion, creed, sex, gender, gender identity/expression, age, veteran status, political affiliation, sexual orientation, medical condition, genetic information, marital status, or disability.
At Adela, everyone belongs.