Principal Software Design Quality Engineer-Medical Device

Elbit America • Merrimack, NH

1d

About The Position

At HiArc, we believe clients don’t need another vendor; they need a strategic partner who gets it. One who listens harder, thinks deeper, and builds smarter—around their needs, products, and goals. HiArc engineers and manufactures complex medical technologies with one goal in mind: creating the perfect fit for our clients. No off-the-shelf thinking. No compromises. Just a tailored, high-performance solution our clients need, the way they need it. That’s why HiArc is the most client-centered partner in the market. We fuse design, engineering, and manufacturing into a seamless, collaborative process—crafted entirely around our clients. We operate as an extension of our clients' teams, de-risking their processes and accelerating their path to market. And the result is a solution you won’t find anywhere else.
Join our team! We hire experts in hardware and software design, robotics, optics, fluidics, chemistry integration, motion and thermal control, risk management, supply chain management, performance testing, advanced manufacturing techniques, finance, human resources, sales, and marketing.
For more information, please visit HiArc.
MAJOR JOB OBJECTIVES
The Principal Software Design Quality Engineer will work as a member of a cross-functional project team engaged in new product development. The individual will serve as a quality representative on product development programs and will work closely with Project Management, System Engineering, Software Engineering, Engineering, and Manufacturing. This individual will be responsible for providing quality leadership, guidance, and support in quality system methodologies for ensuring that the medical device and software development deliverables are executed and released that meet customer expectations, regulatory requirements, applicable standards and company policies and procedures. This role will be a key member of product development teams and will have the opportunity to influence the product design direction based on the customer needs, product reliability expectations, and performance requirements.
PRINCIPAL RESPONSIBILITIES
The Principal Software Design Quality Engineer will be responsible for providing quality leadership, guidance and support in quality system methodologies for medical device product and software development. This includes:
Serve as the quality representative on development teams engaged in new product development of medical devices and medical device software.
Support design and development planning, design input and design output activities, risk management activities, Design and Development File management, design transfer activities, change management, and design reviews for medical devices and medical device software.
Lead Quality Assurance programs and ensure plans are in place to provide and maintain the quality levels for assigned projects in accordance with regulatory requirements, contractual requirements and product specifications.
Ensure products are developed and released that meet customer expectations and regulatory requirements including 21CFR820, ISO 13485, ISO 62304, and ISO 14971.
Support development and approval of design verification and design validation documentation, risk management documentation, product documentation, specifications, and drawings.
Support process development, test method development, and associated validation activities.
Use statistical tools and techniques to analyze and evaluate trends, investigate failures, determine root cause and take appropriate corrective actions to prevent recurrence where appropriate.
Oversee qualification and testing requirements, initiate required customer reports and lead/support corrective action efforts on failures/defects.
Experience in developing or enhancing risk-based product and software development processes that meets global regulatory standards and regulations.
Supporting software tool development and validation.
Facilitate integration of new products into manufacturing.
Ensure company policies, procedures, practices and facilities comply with all applicable customer and regulatory requirements.
Any other emerging quality related duties as identified and assigned.
POSITION REQUIREMENTS
BS degree in Engineering, Biomedical Engineering, Computer Science, or other technical fields.
8 years minimum of related experience in the application of design controls and risk management in the IVD or Medical device industries.
Strong working knowledge of software development life cycle models within a complex hardware/software development system.
Strong understanding of Quality Systems, Design Controls, 21CFR820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366 and applicable medical device regulations.
Strong, demonstrated ability to think out of the box to provide technically sound Quality Assurance and Quality System solutions to designated programs to achieve business results and maintain high levels of quality and compliance.
Ability to assess, make critical decisions, and articulate risk when evaluating a situation.
Proficiency in risk management techniques and experience leading others through process mapping exercises and coaching others in problem solving is desired.
Demonstrated experience working with contract manufacturing, suppliers and customers.
Excellent communication, problem solving, organizational and interpersonal skills are required.
Strong project management skills preferred.
Professional certifications (CQE, CSQE) are desired.
#LI-SW1
Here Are Some of the Great Benefits We Offer:
Most locations offer a 9/80 schedule, providing every other Friday off
Competitive compensation & 401(k) program to plan for your future
Robust medical, dental, vision, & disability coverage with qualified wellness discounts
Basic Life Insurance and Additional Life & AD&D Insurances are available
Flexible Vacation & PTO
Paid Parental Leave
Generous Employee Referral Program
Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
Voluntary Tricare Supplement available for military retirees
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
If you encounter issues with your application, please email [email protected]

Requirements

• BS degree in Engineering, Biomedical Engineering, Computer Science, or other technical fields.
• 8 years minimum of related experience in the application of design controls and risk management in the IVD or Medical device industries.
• Strong working knowledge of software development life cycle models within a complex hardware/software development system.
• Strong understanding of Quality Systems, Design Controls, 21CFR820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366 and applicable medical device regulations.
• Strong, demonstrated ability to think out of the box to provide technically sound Quality Assurance and Quality System solutions to designated programs to achieve business results and maintain high levels of quality and compliance.
• Ability to assess, make critical decisions, and articulate risk when evaluating a situation.
• Excellent communication, problem solving, organizational and interpersonal skills are required.

Nice To Haves

• Proficiency in risk management techniques and experience leading others through process mapping exercises and coaching others in problem solving is desired.
• Demonstrated experience working with contract manufacturing, suppliers and customers.
• Strong project management skills preferred.
• Professional certifications (CQE, CSQE) are desired.

Responsibilities

• Serve as the quality representative on development teams engaged in new product development of medical devices and medical device software.
• Support design and development planning, design input and design output activities, risk management activities, Design and Development File management, design transfer activities, change management, and design reviews for medical devices and medical device software.
• Lead Quality Assurance programs and ensure plans are in place to provide and maintain the quality levels for assigned projects in accordance with regulatory requirements, contractual requirements and product specifications.
• Ensure products are developed and released that meet customer expectations and regulatory requirements including 21CFR820, ISO 13485, ISO 62304, and ISO 14971.
• Support development and approval of design verification and design validation documentation, risk management documentation, product documentation, specifications, and drawings.
• Support process development, test method development, and associated validation activities.
• Use statistical tools and techniques to analyze and evaluate trends, investigate failures, determine root cause and take appropriate corrective actions to prevent recurrence where appropriate.
• Oversee qualification and testing requirements, initiate required customer reports and lead/support corrective action efforts on failures/defects.
• Experience in developing or enhancing risk-based product and software development processes that meets global regulatory standards and regulations.
• Supporting software tool development and validation.
• Facilitate integration of new products into manufacturing.
• Ensure company policies, procedures, practices and facilities comply with all applicable customer and regulatory requirements.
• Any other emerging quality related duties as identified and assigned.

Benefits

• Most locations offer a 9/80 schedule, providing every other Friday off
• Competitive compensation & 401(k) program to plan for your future
• Robust medical, dental, vision, & disability coverage with qualified wellness discounts
• Basic Life Insurance and Additional Life & AD&D Insurances are available
• Flexible Vacation & PTO
• Paid Parental Leave
• Generous Employee Referral Program
• Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
• Voluntary Tricare Supplement available for military retirees

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees