What are the responsibilities and job description for the Director Sustaining Engineering position at React Health Holdings, LLC?
POSITION: Director Sustaining Engineering
FULL-TIME/PART-TIME: Full Time
LOCATION: Bothell, WA
React Health is a fast paced, growth oriented, manufacturer and distributor of medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers. React Health sells and supports its product and services in the acute-care, non-acute and home medical equipment markets. React Health has built a model that combines manufacturing and distribution of products and services to meet the challenges of the undiagnosed as well as those needing therapies after diagnosis in the sleep and respiratory population.
GENERAL SUMMARYWe are seeking a highly skilled Director of Sustaining Engineering with a strong background in mechanical engineering. Responsibilities include designing, analyzing, and maintaining mechanical components and systems, utilizing CAD software and other tools for new parts and prototypes, and conducting performance and reliability testing to meet all specified product and regulatory requirements. The role involves troubleshooting mechanical issues, planning and improving products, and managing sustaining engineering. The Director will oversee manufacturing processes, test and automation equipment, and equipment calibration. They will set departmental priorities, plan for engineer growth, and work cross-functionally with site leadership, Quality, and Production departments.
QUALIFICATIONS
- Bachelor's degree in Mechanical Engineering or related field
- 10 years of experience in hardware engineering
- Strong leadership and management skills
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment and manage multiple projects simultaneously
- Experience with manufacturing engineering, test and automation equipment, and equipment calibration
- Hands-on experience with mechanical engineering
- Must be able to work effectively with diverse groups of people.
Preferred Education
- Master’s degree
- DMAIC or Six Sigma certifications
Preferred Experience
- Previous experience developing mechanical systems for a medical device, or other safety critical application
- Excellent attention to detail and project management skills.
- Excellent written/oral communication skills required.
- Experience with quality control systems, preferably with medical devices as well as in a GMP/ISO environment
- Good problem solver familiar with root cause analysis techniques
- Computer proficient; confident using data analysis programs and Microsoft Suite
- Experience using CAD (computer aided design) software, preferably SolidWorks.
- Ability to assimilate data, recognize key variables and develop/control input/output relationships.
- Ability to work towards outcomes. Does not confuse efforts with results.
Physical Demands
- Requires normal visual acuity and hearing.
- Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.
- Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
- Additional skills may be required to perform additional task(s) specific to work location, department, or line of business.
Working Conditions
- Predominantly operates in an office environment and engineering lab area.
DUTIES AND ESSENTIAL FUNCTIONS
The Director of Sustaining Engineering typically has a range of duties and essential functions, including:
- Directing and overseeing all sustaining engineering activities within the organization. This includes managing a team of development and manufacturing engineers, setting departmental priorities, and planning for the growth and development of the engineering team.
- Leading the design, analysis, and maintenance of mechanical components and systems. This involves utilizing CAD software and other tools to develop specifications for new parts and prototypes, and conducting performance and reliability testing.
- Analyzing and troubleshooting mechanical issues or failures to identify root causes and develop solutions.
- Overseeing manufacturing engineering processes to ensure efficient and effective production of hardware products. This includes managing test and automation equipment and ensuring proper equipment calibration.
- Creates and implements the organization’s sustaining engineering strategy, develops policies, and procedures to support the functional infrastructure.
- Works cross-functionally with site leadership, Quality, and Production departments to align priorities and drive projects forward.
- Effectively communicate conceptual designs and specifications to stakeholders, and leading customer and partner technical interface meetings.
- These responsibilities ensure that the Director of Sustaining Engineering plays a crucial role in the development and maintenance of high-quality hardware products.
- Provide design input, where required, and/or consultation on product/process improvements. Responsible for drawing and/or specification changes associated with the ongoing maintenance of existing designs.
- Establish requirements for reliability of components/assemblies and conduct design verification testing in collaboration with Quality team members. Support development of protocols/reports, management of 3rd party resources, and review of verification results. Design of fixtures and test equipment to execute protocols where required.
- Responsible for establishing product (and associated parts/sub-assemblies) requirements with respect to product performance and compliance with applicable standards informing test specifications.
- Determine impact of proposed design changes (change impact analysis).
- Proactive approach to drive design/product improvements from manufacturing yields, service records, clinical feedback, and customer input.
- Utilize Root Cause Analysis tools to define the problem, contain the issue, identify causes, and implement validated corrections.
- Create/review mechanical part drawings, assembly drawings, and BOMs using 3D CAD software.
- Work according to Project Plan and Company QA Manual.
- Maintain current QA training, as required, and attend seminars and training sessions necessary to maintain appropriate level of professional competence.
- Attends and participates in departmental meetings and performs all duties necessary for the department as per department policies and procedures. Ensures all department compliance guidelines are met.
- Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department
- Maintains product and company reputation by complying with government regulations.
- Coordinate prototype and pilot builds of mechanical assemblies with cross-functional team members.
- Plan and manage multiple projects simultaneously. Estimates, tracks & completes projects on time and within budget.
Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care. React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace. We are an Equal-Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Job Type: Full-time
Pay: $140,000.00 - $170,000.00 per year
Salary : $140,000 - $170,000
