Hyperbaric Modular Systems, Inc. is a highly successful, internationally operating small-sized medical technology company specializing in the production of pressure chamber systems for the fields of medical technology, pilot training, diving technology, and deep and tunnel construction.

The Technical Project Engineer is responsible for contributing to product development projects and for performing as an internal liaison between the engineering department and operations, manufacturing, and RA/QA departments for the purpose of scheduling and driving medical device and consumer product projects designed and developed by HMS, from concept to commercial launch.

Required Skills, Qualifications, and Experience:

● Minimum of 5 years’ experience in a technically focused project management role in the medical device industry.

● Minimum of 10 years’ experience performing as a technical lead, functioning as a systems engineer or a design engineer on pressure vessels, piping design, or hyperbaric chambers.

● Proficient in the use of 2D/3D CAD software, preferably AutoCAD Mechanical/AutoCAD Inventor.

● Ability to travel domestically and abroad in support of hyperbaric chamber installation activities.

● Experience with all phases of product development process and new product introduction (NPI) (feasibility, core development, transfer to manufacturing, sustaining engineering, and cost reduction) in a regulated environment.

● Proficient in the use of Project Management Tools for planning, work breakdown, scheduling, task estimation, and collaboration.

● Working knowledge of regulated product development activities and working knowledge of quality system regulations

● Proven ability to lead cross-functional design teams in highly dynamic and fast-paced environments.

● Effective communication, impeccable organizational, and essential time management skills.

● Demonstrated ability to create, maintain, and report program status utilizing industry standard tools

● Excellent leadership skills and experience leading high-performance teams required

● Comfortable with programs that cross technology boundaries of software, hardware, and systems development

Responsibilities:

● Establish, implement, and administer an effective project management structure to ensure rapid development of HMS’s products and service offerings, which may include non-regulated and regulated pressure vessels for human occupancy.

● Support cross functional teams through the medical device product development lifecycle (from concept to regulatory filings, i.e., FDA, Health Canada, and subsequent commercialization).

● Ensures implementation and compliance with NEC, IEC(UL) 60601-1, UL 508A, NFPA 99, ASME PVHO-1, quality system standards and applicable regulatory requirements.

● Responsible for synthesizing the project work breakdown structures, schedules, and project risk into integrated project plans.

● Works independently or with cross-functional teams to lead and support multiple projects, balancing priorities, and resources to meet project and management expectations.

● May lead or support installation activities domestically and abroad.

● Follows established procedures and medical device regulatory requirements for product development and sustaining engineering activities.

● Communicates and presents routine project status updates to the organization’s top management.

● Manage multiple projects and tasks simultaneously and effectively influence, negotiate, and communicate with internal and external stakeholders, partners, contractors, and vendors to ensure project deliverables adhere to planned timelines.

● Identify, recommend, and introduce program management tools.

● Recommend, implement, monitor, report and improve key program metrics including but not limited to scope, requirements, budget, resource consumption, and schedule.

● Directly and indirectly lead internal teams to achieve goals within stated timelines.

● Maintain compliance with all company policies, quality systems, and procedures.

Education:

● Bachelor's degree or higher in mechanical engineering.

● Demonstrated proficiency in the use of 2D/3D CAD software, preferably AutoCAD Mechanical/AutoCAD Inventor.

● Experienced in Hyperbaric System Design and Development (desired)

Job Type: Full-time

Pay: $72,574.73 - $87,401.84 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• San Diego, CA 92154: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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