About Senseer:

Founded in 2017 to address the high failure rate of implantable devices, Senseer Health develops smart medical device sensors to track and manage device status and condition in real-time. Our goal is to minimize unnecessary procedures and revision surgeries through the use of our novel sensors.

About this role:

The Senior Systems Engineer II will act as the technical lead of Senseer’s R&D team for medical device development projects, both sustaining and new feature development. The position will take user needs, business needs, regulations, risk analyses, and system constraints to define product requirements and sub-system requirements. Throughout the product lifecycle, the systems engineer will assess and evaluate the system design to ensure the user needs are being met.The position will manage third-party design firms, manufacturing providers, and contract research organizations while developing the product from prototype through commercialization. In addition, the systems engineer is expected to design, prototype, and support laboratory testing for product concepts and test fixtures with the support of the R&D team.

About you:

● Strong leadership skills with initiative to seek out answers to questions and problems.

● You can work independently and are able to deal with ambiguity.

● You desire to work in a high velocity startup where collaboration is required.

● You are an excellent communicator, detail-oriented, and experienced working within a QMS.

Responsibilities:

● Independently manage and lead a multi-disciplinary R&D team on complex medical device projects from planning through completion.

● Be responsible for medical device system definition, architecture, behavior, and performance in collaboration with hardware and software engineering functions.

● Identify both technical and project risks as well as mitigation strategies to use during product development.

● Work with team members to define testing strategies and test tools used in verification and validation

● Manage third-party service providers: providing requirements and a scope of work, analyzing proposals, setting expectations, overseeing development work, ensuring regular communication, and facilitating project completion.

● Contribute to and provide leadership on mechanical, electrical, and enclosure designs.

● Design and execute experiments, including creating test setups and methods, to assist prototype iteration.

● Manage documentation and compliance with a Quality Management System (QMS).

Qualifications:

● BS in Engineering or directly related field; Electrical or Mechanical Engineering backgrounds highly desired.

● 5 to 7 years of experience as a product development engineer in medical devices.

● Experience working on development projects from initial concept to market release, product definition, system architecture, design & development, verification & validation, and transfer to manufacturing.

● Experience managing third-party organizations to provide required project deliverables.

● Experience with 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1 and collaterals, IEC 62366, and IEC 62304.

● Hands-on laboratory experience, from hypothesis through conducting experiments and analyzing results.

● Expertise with biomedical product design, plastic consumable design, and/or contract manufacturing is desired.

● Experience managing small engineering teams is a plus.

● Experience with MEMS design, fabrication, and/or testing is a plus.

Requirements:

● Ability to work in the United States. We are unable to offer any sort of sponsorship for this role.

● Ability to work locally in Pasadena, CA. This hybrid role is a mix of remote and in-person work, depending on project needs.

● Experience in design of experiments (including applied statistics).

Additional Details:

● Compensation includes a base salary, benefits (medical, dental, vision), and equity.

● A rapidly expanding team with opportunities for career advancement and professional development.

Pay: $125,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Relocation assistance
• Vision insurance

Work Location: Hybrid remote in Pasadena, CA 91103