Principal Systems Engineer

We are seeking a talented Principal Systems Engineer to join our elite Systems Engineering group. In this role, you will be responsible for leading SDD’s commitments to product feature scoping, system architecture, design, and integration in both the novel, miniaturized Caridac Rythm Management product development space as well as SDD’s broader, platform-focused technology development initiatives. Fluency in supporting product realization throughout the full arc of life-cycle steps ranging from early concept work; to formal project initiation; through the end of verification and validation will prove fundamental. Candidates will necessarily bring deep technical expertise and a complimentary track record of critical thinking, effective verbal and written communication, as well as the capacity to coordinate robust collaborative engagements with a variety of technical, end-user, and business-oriented stakeholders.

Your Responsibilities

• Contextualizing patient and clinical use expectations to drive design inclusions and lasting development decisions; fostering product embodiments that meaningfully serve market and end-user needs
• Garnering/coordinating technical alignment across a wide variety of partners/customers/teams to determine and structure system design architectures and segment features across sub-systems
• Critical thinking to distill crucial design trade-offs and propose clean, path-forward technical solutions
• Pragmatic/rational support for broad-spectrum functional system risk analyses to ensure patient safety while, at the same time, sidelining, “gold-plated” design concept embodiments
• Timely reporting of technical status to management, program management, and sub-system teams in concise/routine/archivable manners through strong written/verbal/graphical communication skills [Note: Candidates will need to submit a writing sample, inclusive of referenced visuals, for review]
• Crafting/managing technical documentation to ensure partnering sub-teams have clear input/guidance, inclusive of testable requirements, in the regulated/process-controlled Class III medical product space
• Algorithm development, especially in support of early-stage feature development explorations

Your Profile

• BS Degree in an engineering discipline or related technical and/or life-science field
• 5 years experience as a Systems engineer working in accordance with ISO/IEC/IEEE 15288 [Note: Stated explicitly, we are NOT seeking IT Systems Administrators/Engineers]
• 3 years experience in the medical device (or similarly-regulated – e.g., aerospace) industry
• Demonstrable success in driving one or more strategic, multi-faceted projects to completion
• Experience with issue management (per ISO 14971 and IEC 62304 for those with medical device backgrounds), in service of development work bug documentation/dispositioning
• Baseline computer programming skills, inclusive of the ability to review embedded software, digital logic, and hardware description language (HDL)

Additional Preferred Knowledge, Skills, Abilities

• Degrees in electrical and/or systems engineering (especially Masters-level) are generally preferred
• Experience in active CRM therapy product development, especially with miniaturized device types
• Versed on Internationally Council on Systems Engineering (INCOSE) best practices
• System simulation experience (e.g., SysML, Python/MATLAB, ANSYS, AMD Vivado [formerly Xilinx], etc.)
• Familiarity with international standards relevant to product realization in the Class III medical product space especially in regard to relevant system requirements interfacing strategies
• Previous experience in leading taskforce investigational initiatives (e.g., helming of “tiger teams”)
• Versed on the Usability process as outlined in IEC 62366-1

Physical & Travel Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week.
• Must be able to travel to other office locations.
• Must be able to travel internationally and domestically, less than 5% of the time.

Location

• Lake Oswego, OR this is a hybrid position.

About MSEI:

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company’s core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

EEO Commitment:

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.