Medical Devices System Engineer

RESOLVEM USA; Irvine (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

RESOLVEM USA is seeking a highly skilled System Engineer to design and update DHF/DMR records, lead technical teams, and drive new capital equipment introductions for medical devices. You will interface with distributed design teams and customers, manage project plans, tests, and documentation, and travel up to 25% globally.

The role requires a Bachelor’s in Mechanical or Electrical Engineering, 5+ years in engineering with medical devices, and 3+ years of cross-functional leadership in SW/HW.

Qualifications

• Bachelor's degree in mechanical or electrical engineering required.
• 5+ years in engineering with product development responsibility in medical devices.
• 3+ years of cross-functional technical leadership in system engineering (SW/HW).
• Experience with design control, ECOs, CAPAs, and software version control preferred.

Responsibilities

• Write system specifications, architecture, and design.
• Lead sub-system teams and document top-level design.
• Plan and conduct system integration and Proof of Design tests.
• Plan verifications and validations for systems and sub-systems.
• Develop simulations/models and lead feasibility studies.
• Interface between external vendors and customer teams.
• Conduct bench, V&V testing and produce reports.
• Ensure compliance with electrical standards for medical devices.
• Perform software evaluations and system analysis.
• Travel up to 25% to customer sites.

Skills

System engineering

Technical leadership

Software development

Medical devices knowledge

Education

Bachelor’s degree in Mechanical/Electrical Engineering

Job description

Job Description

Job Description

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!

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&B, 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.

Company Description

RESOLVEM 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.

We focus on the details so our customers can concentrate on the big picture—driving key design improvements and meeting customer needs.