THE COMPANY: 

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients.  Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm.  Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

The Senior Manager, Systems Engineering will be responsible for overseeing the system engineering functions for developing and implementing improvements and new features for existing products as well as the design and development of next generation products. Systems Engineering functions include aiding in requirements definition, system architecture, concept generation, prototyping, design, verification and validation testing and reporting, tracing, design documentation, troubleshooting, and production support while ensuring quality and compliance. The individual will be a hands-on leader with technical acumen to clarify technical challenges and provide guidance to the teams.  In addition, the individual will work closely with cross-functional teams to continuously monitor the performance of the Jewel device in the field and provide direction to other engineering functions on the projects pipeline. The individual should be able to thrive in a fast-paced, high-growth and dynamic environment.

RESPONSIBILITIES:

• Oversee the development of system-level product requirements and subsystem interface specifications to ensure products meet functional, performance, safety, and regulatory requirements
• Collaborate with cross-functional teams including Quality, Clinical, Commercial, and User Experience to gather input and secure buy-in for requirements and specifications
• Lead solutions to complex system-level design problems, considering trade-offs between user needs, business goals, technical complexity, and schedule constraints
• Oversee the development and maintenance of a comprehensive trace matrix to ensure complete traceability between requirements, design artifacts, and test cases
• Oversee design change impact / change analysis and development of regression test plans
• Oversee system-level design characterization and verification & validation activities to ensure product safety and compliance
• Oversee device investigations related to manufacturing nonconformances and field issues, as needed, collaborating with Quality and engineering subject matter experts
• Lead data analysis efforts to assess product performance, communicate findings to technical and non-technical audiences, and propose data-driven improvements
• Stay current on national and international standards relevant to product design, medical device landscape, and regulations related to company’s products
• Work cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams to ensure alignment on root cause analysis, design & configuration approaches, testing strategies, documentation releases, etc.
• Ensures the Systems team personnel are available, as necessary, to support other engineering and cross-functional teams to meet product development objectives
• Foster a culture of continuous learning and improvement by actively coaching and mentoring team members, identifying their strengths and areas for development

PHYSICAL DEMANDS:

• The employee will sit for long periods of time during travel.
• The employee will walk frequently within hospital facilities.
• The employee will be required to crouch, kneel, stoop, balance, and reach.
• The employee shall be able to lift up to 40 lbs.
• Specific vision abilities required by this job include color vision, near and far vision, and depth perception.

QUALIFICATIONS:

• Bachelors in Mechanical, Electrical, Biomedical Engineering. Advanced degree preferred
• 12+ years of experience in product development of electro-mechanical systems with a significant portion being medical device experience
• 6+ years of managing teams in medical device space
• Experience with FDA regulations, GMP, and ISO requirements
• Thorough understanding of 21 CFR Part 820 Subpart C Design Control and demonstrated success managing large cross-functional product development projects through Design Control
• Extensive experience in product definition, requirements development and maintenance, system level risk analyses, and DFMEAs
• Ability to drive the implementation of solutions to complex system-level design problems largely autonomously, leveraging Engineering subject matter expertise and cross-functional input as needed
• Proficiency in data mining, processing, visualization, and statistical tools and languages such as: MATLAB; Python; R; Excel; Minitab etc. preferred

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $185,000 - $196,000 + Annual Bonus