Sr. Systems Engineer

The role

Job Description

The Senior Systems Engineer will lead new product development efforts at Access Vascular Inc., with primary ownership of design control and risk management processes throughout the product lifecycle. This role is responsible for driving all V&V testing programs, including managing external third-party engineering, manufacturing, and testing partners, ensuring all development activities are conducted in compliance with applicable regulatory standards. This individual ensures that best engineering practices and efficient processes are employed to meet technical, regulatory, and business objectives.

All jobs

Sr. Systems Engineer

Access Vascular, Billerica, MA

Posted pay

$120K–$155K

a year

Compared with similar jobs

This base pay is below the median for senior infrastructure, platform and SRE jobs in other US places.

Median: $181K a year
Other jobs in the group: 834

We compare the middle of each posted range. This is base pay as posted. The group does not include this job.

Location: Billerica, MA
Work type: Not given
Level: Senior
Experience: 7+ years
Skills in the job text: Python
C++
C
Jira
Posted: Jul 15, 2024
Last check: 2 h ago
Job type: Infra, platform & SRE

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Access Vascular

Open tech jobs: 1
With posted pay: 100%

About Access Vascular: funding, hiring and pay

Access Vascular

About Access Vascular: funding, hiring and pay

Company facts

Money raised: At least $40.5MSum of SEC filings. A filing does not show all money that a company raises.
Newest raise: Oct 13, 2023First sale on an SEC filing

Funding records can have errors and can be missing. The company page has the links.

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The role

Job Description

What you need

Educational Background: B.S. in engineering discipline (e.g., Electrical, Mechanical, Biomedical, Software). M.S. preferred.
Experience: 7+ years’ experience in medical device product development, including FDA regulated devices covered by 510(k) or PMA. Demonstrated hands-on experience leading design control and risk management programs required. Prior startup or early-stage company experience — comfort with ambiguity, rapid iteration, and wearing multiple hats.
Leadership: Proven effective motivational leadership skills, with experience in building and managing teams to deliver product designs on schedule. Experienced in managing third-party engineering and manufacturing partners, including supplier qualification and technical oversight.
Technical Proficiency: Proficient in the design of systems with mechanical, electrical, and software elements. Working knowledge of ECG signal characteristics, including waveform morphology, common artifact types, signal conditioning, and clinical measurement standards (AAMI EC57, IEC 60601-2-25). Capable of creative problem solving, quick comprehension, and rigorous skeptical analysis. Proficient with requirements management and traceability tools. Experience with V&V testing and test method validation required. Experience with ECG, cardiac monitoring, or electrophysiology devices strongly preferred. Experience with mechanical, electrical, and software systems required; experience with catheter technologies preferred.
Communication: Excellent verbal and written communication skills to support working within a team and demonstrated ability to communicate complex technical concepts to a diverse audience.
Regulatory Knowledge: Thorough knowledge of applicable standards and regulations, including QMSR, ISO 14971, IEC 60601-1, IEC 60601-1-2 and other collateral standards, IEC 60601-2-25 (ECG equipment), AAMI EC11/EC57, ISO 10993. Familiarity with FDA guidance documents on design controls, software (IEC 62304), and risk management.
Software Skills: Proficient with Microsoft Office Software products, including MS Project,; requirements management tools (e.g., DOORS, Jama, Polarion), collaboration tools (Jira), familiarity with embedded C/C++ or firmware development, Python.

Sr. Systems Engineer

The role

Sr. Systems Engineer

The role

What you will do

What you need

Pay and benefits

About Access Vascular

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Company facts

Access Vascular

Compared with similar jobs