Senior Product Engineer (Medical Devices)

Job Description

A-Line is now hiring a Fully Remote Medical Device Sr. Staff Engineer. This would be full time / 40+ hours per week.

If you are interested in this Sr. Staff Engineer, please email Heather Foret or apply to this posting!

We are seeking a highly skilled Sr. Staff Engineer, Product Development with a focus on Process Architecture to join our dynamic team. 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 will require 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 assignment 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 (Software as a Medical Device), SiMD (Software in a Medical Device), and MDDS (Medical Device Data Systems).

· Analyze the impact of process changes and create implementation plans to roll out new processes.

· Drive the implementation of tooling to facilitate software product delivery and ensure compliance with industry standards.

· Conduct and document validation of tooling to ensure functionality, accuracy, and reliability.

· Create and deliver training and documentation for impacted functional areas.

· Align with BD’s Quality organization to ensure adherence to FDA, cGMP, and other industry practices.

· Maintain accurate Design History Files (DHF) and up-to-date records of validation activities.

· Continuously identify opportunities for process and tool improvements.

o Program Management:

· Serve as Program Manager for tooling delivery and occasionally for the delivery of BD Software products.

· Manage software delivery projects using Agile and/or SAFe methodologies.

· Facilitate the identification of program risks and issues and develop mitigation plans.

· Provide Scrum Master leadership, coaching, and mentoring to scrum teams.

o Analytical and Problem-Solving Skills:

· Strong attention to detail in documentation and validation processes.

· Ability to assess complex situations and develop effective remediation plans to enhance compliance and efficiency.

o Communication and Collaboration:

· Exceptional verbal and written communication skills, capable of conveying complex information clearly.

· Proven ability to work collaboratively with cross-functional teams including engineering, product management, quality assurance, and IT.

Sr. Staff Engineer Requirements

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

o Experience:

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

· Strong background working in compliance with 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485.

· Experience with cloud-hosted software development and the full software development lifecycle (SDLC).

· Practical knowledge of Agile software development principles.

· Experience leading cross-functional teams toward operational objectives and identifying operational efficiencies.

o Skills & Abilities:

· Strong communication skills, with the ability to teach new concepts and deliver complex messages.

· Experience in managing multiple projects and setting priorities in a fast-paced environment.

· Experience with matrixed resources in assigned programs or projects.

· Certified Scrum Master (CSM) certification is desired.

If you think this Sr. Staff Engineer is a good fit for you, please reach out to me by e-mail, or apply to this posting!

Full-time

Fully remote