Sr Mechanical Verification Engineer

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity.

Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life.

This position is responsible for the Design Verification function within Kestra reporting directly to the Electrical Engineering Manager. This position is Primarily responsible for design verification and qualification for research and development projects that support the long term vision and strategic plan. Coordinate resource and timing needs for development and support projects. Responsible for ensuring process and quality improvements are driven within the design verification organization and the PDP process.

Provide strong leadership skills to the department and business.

ESSENTIAL DUTIES

Read and interpret medical device standards for safety and essential performance to ensure that test protocols are written appropriately to ensure compliance.

Read and interpret EMC and FCC standards to ensure that test protocols are written appropriately to ensure compliance.

Develop verification and qualification test protocols for verifying system, hardware, and component level requirements.

Develop verification plans and reports that include traceability to all allocated requirements.

Perform system, hardware, and qualification tests ensuring that test records are accurate and complete.

Proficient use of lab equipment such as 3D printers, laser cutters, drill press, mill, twist and flex apparatus, data acquisition systems and other basic electrical test equipment such as DMMs.

Design, construct, and document test fixtures needed to support verification tests.

Responsible for continuous improvement activities as determined in goals and objectives

Work with all levels of the organization to ensure objectives are being met

COMPETENCIES

Ability to be a self-starter, seek new and better methods, and work with minimum supervision

Demonstrate deep expertise in profession and industry best practices

Ability to write documents that can be easily understood and followed by other team members.

Ability to perform statistical analysis of test results to ensure confidence and reliability requirements are met.

• Ability to collaborate within a Team environment and across functions
• Embrace Kestra’s Mission & Core Values
• Capability to discern relevant facts and in turn, effectively resolve issues
• Ability to be flexible in a fast-paced goal-oriented environment
• Demonstrate the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win

QUALIFICATIONS

• Education/Experience Required: B.S. Engineering or related science field
• Minimum 5 years of related experience
• Mechanical Engineering knowledge, proficient in 3D modeling and design
• Quality systems knowledge & design verification experience
• Medical experience, QSR regulation experience, Manufacturing/operations experience
• Strong passion for improving product and process quality and reliability
• Strong verbal, written and interpersonal communication skills and influencing skills
• Strong decision making and judgment skills
• Preferred: MS in engineering or industrial science
• Six Sigma or Lean Sigma experience
• Knowledge on FDA's Quality System Regulations and OUS Quality System Regulations
• SUPERVISORY RESPONSIBILITIES: None
• WORK ENVIRONMENT
• Indoor open office environment
• Lab environment
• Minimal noise volume typical to an office environment
• Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug
• Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.
• PHYSICAL DEMANDS
• Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
• Frequent stationary position, often standing or sitting for prolonged periods of time
• Frequent computer use
• Frequent phone and other business machine use
• Occasional lifting required, typically between 2-15 pounds
• TRAVEL
• Occasional travel, domestic and international, may be required, less than 20%.
• OTHER DUTIES: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.