Dynamic, High-Impact Role with Global Reach
Are you an experienced professional with a passion for driving success and making a tangible impact? At RESOLVEM, we are looking for a dedicated and motivated individual to take on a dynamic role that offers both challenge and opportunity. This position offers the chance to work with cutting-edge medical device companies, lead impactful projects, and work directly with a diverse team across multiple time zones. With up to 25% travel, this role requires someone who thrives in a fast-paced, global environment, enjoys problem-solving, and is committed to ensuring our customers’ success. If you have the drive to grow within a forward-thinking company and are excited about contributing to the future of medical device manufacturing, we want to hear from you!
To apply, use this link (DO NOT EASY APPLY VIA LINKEDIN): https://forms.monday.com/forms/8fccac58b432137e9c64b8e30da3eadd?r=use1
Position Overview:
We are seeking a highly skilled and detail-oriented system engineer to help our customers in design (DHF and DMR development) of new versions of products, direct and design internal development projects, and set up new product introduction (to manufacturing) of capital equipment products.
In this role, you will learn new technologies and lead technical teams to develop systems that interface with these technologies. You will act as the liaison between our distributed design and engineering teams and our customers. This role encompasses project planning, technical specification development, test development and test tools development, work scheduling, tracking timely operation of development and engineering teams and development of DHF and DMR records.
Responsibilities:
Write and define system specifications and requirements, System architecture and design, System performance and usability.
• Project/Sub-system technical lead:
Understand customers' needs and write specifications of the system and sub-systems. Collaborate with SMEs to define and document the System architecture and top level design. Support the technical designers in their design and verify fit of the design to system requirements.
• Plan and conduct system integration and Proof of Design tests.
• Plan and conduct system and sub-system verifications and validations.
• Build simulations and models of system functions, and lead feasibility studies.
• Act as liaison between external vendors and customer team.
• Perform measurements, creating engineering designs, developing plans and keeping laboratory notebooks on all work
• Conduct testing (Bench, V&V, in vivo) developing and utilizing test protocols and generating written reports.
• Recommend and enforce design for compliance to electrical standards for medical devices.
• Conduct software evaluations, reviews and system analysis
• Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed
Qualifications:
Education: · Bachelor’s degree in Mechanical, electrical engineering or equivalent is required.
Required Experience: 5+ years of experience in engineering practice including technology or product development responsibility in medical devices along with three (3) years of experience providing technical leadership on cross-functional teams in system engineering of multi-disciplinary products (SW and HW). Must have experience in development processes and in documentation writing
Experience with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control is preferred.
Experience in the Medical Device or the Aerospace industries is preferred.
Knowledge of medical device electrical standards such as the IEC 60601 family of standards is preferred.
Knowledge and experience with software development and programming (for tools and data analysis) is required.
Other Duties/Standards:
The job is a hybrid job requiring at least 3 days of work in the office. Depending on the project assigned, the company reserves the right to require work in the office for 5 days a week.
The job requires independent work with limited supervision.
The job requires work with multiple time zones around the world and a flexible work schedule.
This job requires legal authorization to work in the United States.
The job may require up to 25% travel to partners and customers’ sites.
The above descriptions are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. RESOLVEM utilizes the multi-skill concept and expects the employee to perform other job disciplines. RESOLVEM retains the discretion to add or change the functions and duties of the position at any time and is an equal opportunity organization.
To apply, use this link: https://forms.monday.com/forms/8fccac58b432137e9c64b8e30da3eadd?r=use1
Company DescriptionRESOLVEM is an engineering services company specializing in transferring product designs to design control and manufacturing. We work with companies that develop medical devices, helping them bring their designs under design control, transform prototypes into market ready products, prepare them for mass manufacturing, and support their pilot manufacturing and transition to commercial-scale production.Company: RESOLVEM Inc. | Location: Irvine, CA / Carlsbad, CA (On-site) | Full-time | Entry level
Apply here: https://wkf.ms/4r5G7rk
About the job
Most entry-level EE jobs put you in a corner running the same test for a year. This one doesn't.
At RESOLVEM Inc., you'll touch the entire medical device development lifecycle in your first year. That's the kind of experience that normally takes 5+ years to accumulate at a big company. You'll design circuits that go into actual field operation of medical line test equipment and medical products, hunt down failures at the bench, and learn the regulated-industry skills that make medical device engineers stand out. All this with direct mentorship from senior engineers who've done this for decades.
Why RESOLVEM?
We're an engineering services firm specializing in R&D design support of new products and transferring product designs to design control and manufacturing. We help medical device companies bring their designs under design control, prepare them for mass manufacturing, and support their pilot manufacturing and transition to commercial-scale production. Because we work across multiple clients and products, you won't spend years on one subsystem. You'll build breadth and depth, fast.
What you'll do
• Design real circuits. Capture and maintain schematics for analog, digital, power, and mixed-signal circuits, including sensor interfaces and microcontroller-based subsystems. Perform PCB layout in Altium Designer (OrCAD, PADS, or KiCad also welcome), applying IPC standards and DFM/DFT principles. Run LTspice/PSpice simulations to prove your design before it hits copper.
• Own the bench. Build and use custom benchtop test equipment and fixtures. Measure and debug with oscilloscopes, logic analyzers, spectrum analyzers, power meters, DMMs, and programmable supplies/loads. Automate it all with Python, MATLAB, or LabVIEW.
• Hunt down failures. Perform electrical failure analysis and root cause analysis where your findings drive real design decisions. Create investigation reports and support corrective actions.
• Review and improve designs. Participate in design reviews, compare design revisions, and create Engineering Change Orders (ECOs) that keep controlled documentation current.
• Learn the regulated world fast. Work within a certified quality management system (ISO 13485, FDA 21 CFR 820) and design control processes. Contribute to Design History File (DHF) deliverables and requirements traceability. Apply ISO 14971 risk management (DFMEA, hazard analysis inputs), support IEC 62304 software lifecycle activities, and get hands-on with EMI/EMC design and pre-compliance testing for IEC 60601-1-2.
• Build complete products, not just boards. Select components; create BOMs, purchasing specifications, and engineering drawings; support obsolescence assessments. Develop firmware for microcontroller-based designs using C/C++ and protocols like I2C, SPI, and UART. Author and execute V&V protocols and reports, support test method validation (TMV), and contribute to process development, inspection criteria, statistical data analysis, and equipment qualification (IQ/OQ/PQ).
• See your work ship. Collaborate with mechanical, systems, software, test, quality, and manufacturing engineers, plus customers and contract manufacturers, from prototype through pilot manufacturing to commercial-scale production. Communicate your results through written reports, presentations, and design reviews.
You bring
• BS in Electrical Engineering from an accredited university
• 1-3 years of work experience
Note: must have at least one year full time paid commercial experience
• Hands-on schematic, simulation, and PCB layout/design experience
• Comfort at the lab bench (oscilloscopes, logic analyzers, spectrum analyzers, power meters) and curiosity about how things fail
• Experience with electrical failure analysis and root cause analysis, including reports and investigations
• Working knowledge of analog and digital circuit fundamentals and troubleshooting
• Proficiency in at least one of MATLAB, Python, or C/C++
• Strong written and verbal technical communication; able to present findings in design reviews
• Problem-solving skills and the ability to work independently and in a team-oriented environment
Bonus points for
• Experience in a medical device or otherwise regulated environment (ISO 13485, FDA 21 CFR 820, design controls, DHF)
• Familiarity with IEC 60601-1, IEC 60601-1-2 (EMC), ISO 14971, and/or IEC 62304
• Altium Designer proficiency;
• Python or other automated test development experience
• Monday.com or similar project management tools; Agile/Scrum/Waterfall methodologies
• Familiarity with IPC standards and DFM/DFT practices
The details
• $75,000-$95,000/year depending on experience, education, and demonstrated skills (posted range complies with California pay transparency requirements, SB 1162)
• Full-time, exempt position reporting to the Electrical and Systems Engineering Manager (R&D / Operations)
• In-person in Irvine or Carlsbad, CA, 4-5 days per week, with up to 20% travel to customer and contract manufacturing sites
• Must be legally authorized to work in the US
• Able to work for extended periods at the lab bench, handling small components with ESD-safe practices, occasionally lifting up to 25 lbs of test equipment
If you want to become the engineer who can take a medical device from napkin sketch to production line, this is where you learn it.
Apply here: https://wkf.ms/4r5G7rk
RESOLVEM Inc. is an equal opportunity employer.
Company DescriptionRESOLVEM is an engineering services company specializing in transferring product designs to design control and manufacturing. We work with companies that develop medical devices, helping them bring their designs under design control, transform prototypes into market ready products, prepare them for mass manufacturing, and support their pilot manufacturing and transition to commercial-scale production.