Senior Product Engineer (Medical Devices)

ZipRecruiter; San Diego (CA); Remote; USD 158,000; Full time

Job summary

A leading company is seeking a Fully Remote Medical Device Sr. Staff Engineer to enhance software development processes. The role involves collaboration across teams, program management, and ensuring compliance with industry standards. Ideal candidates will have a strong background in regulated environments and excellent communication skills. This full-time position offers competitive pay and benefits after 90 days.

Benefits

401(k) with company match

Benefits after 90 days

Qualifications

• 6+ years in a regulated healthcare/medical device environment.
• Experience with 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485.

Responsibilities

• Refine software development and release processes for cloud-based deployments.
• Serve as Program Manager for tooling and software delivery projects.
• Ensure adherence to FDA, cGMP, and other industry standards.

Skills

Communication

Analytical and Problem-Solving Skills

Collaboration

Education

Bachelor’s degree in Computer Science

Bachelor’s degree in Business

Tools

Agile

SAFe

Job description

Job Description

A-Line is now hiring a Fully Remote Medical Device Sr. Staff Engineer. This is a full-time position, requiring 40+ hours per week.

If you are interested in this Sr. Staff Engineer role, please email Heather Foret at [e-mail] or apply to this posting!

We are seeking a highly skilled Sr. Staff Engineer, Product Development with a focus on Process Architecture. The ideal candidate will play a pivotal role in proposing, collaborating on, and implementing efficient, compliant business and quality processes for our software development efforts. This position requires strong collaboration with multiple functional teams and stakeholders, along with the ability to drive process improvements across the software development lifecycle.

Sr. Staff Engineer Compensation

• The pay for this position is $76.39/hr
• Benefits are available to full-time employees after 90 days of employment.
• A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates.

Sr. Staff Engineer Highlights

· Shift is Monday-Friday 8am-5pm. Fully Remote, but must reside on the West Coast. Domestic travel up to 5%.

· This position is a contract with potential for permanent hire based on attendance, performance, and business needs.

Sr. Staff Engineer Responsibilities

o Process Analysis, Design, and Execution:

· Refine software development and release processes to support frequent cloud-based deployments of SaMD, SiMD, and MDDS.

· Analyze the impact of process changes and create implementation plans.

· Drive tooling implementation to facilitate software delivery and ensure compliance.

· Conduct and document validation of tooling.

· Create and deliver training and documentation.

· Ensure adherence to FDA, cGMP, and other industry standards.

· Maintain Design History Files (DHF) and validation records.

· Identify opportunities for process and tool improvements.

o Program Management:

· Serve as Program Manager for tooling and software delivery projects.

· Manage projects using Agile and/or SAFe methodologies.

· Identify risks and develop mitigation plans.

· Provide Scrum Master leadership and coaching.

o Analytical and Problem-Solving Skills:

· Attention to detail in documentation and validation.

· Ability to assess complex situations and develop remediation plans.

o Communication and Collaboration:

· Excellent verbal and written communication skills.

· Ability to work collaboratively across teams.

Sr. Staff Engineer Requirements

o Education: Bachelor’s degree in Computer Science, Business, or related field.

o Experience:

· 6+ years in a regulated healthcare/medical device environment.

· Experience with 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485.

· Experience with cloud software development and SDLC.

· Knowledge of Agile principles.

· Experience leading cross-functional teams.

o Skills & Abilities:

· Strong communication skills.

· Experience managing multiple projects.

· Experience with matrixed resources.

· CSM certification is preferred.

If you believe this Sr. Staff Engineer role is a good fit, please contact me via email or apply to this posting.