As a Lead Engineer, Design Assurance, you will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with the R&D and Sustaining Engineering teams in the development and maintenance of Design History Files for Class II cardiopulmonary medical devices to ensure that design control principles are followed, and that safety and efficacy is demonstrated. At all times throughout the process, you will identify and mitigate risks.
Provide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
Ensure compilation and maintenance of product Design History Files.
Partner with R&D and Sustaining Engineering to ensure design reviews are thorough and robust.
Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.
Document traceability of requirements through design output and to design verification and/or design validation.
Insist on early requirements maturation, early test plan/script development, and design input requirements that are indicative of real world use case environment and customer needs.
Participate in cross-functional reviews of software anomalies to prioritize and disposition design defects.
Review intended use validation for non-product software and tools used in the development process.
Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.
Perform DHF audits of other products as an independent reviewer.
Support the CAPA process by performing investigation, root cause analysis and verification of effectiveness checks for design related issues.
Support external regulatory and customer audits.
Collaborate with global Design Assurance team to drive continuous improvement, including development of standard work, striving for a world-class Product Development Process.
Required Background and Competencies:
Bachelor’s Degree in engineering or related field is required; Master’s Degree is preferred
5-10 years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense)
Experience with software development processes is required.
Experience with development of electromechanical systems is preferred.
Strong working knowledge of design controls as required by FDA 21 CFR 820.30, European Medical Device Regulation and ISO 13485 product realization.
Strong working knowledge of software development life cycle process such as IEC 62304.
Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls are a plus.
ASQ or related quality certification is preferred.
Detail oriented with strong organizational and record keeping skills
Problem solving and root cause analysis skills
Systems Engineering knowledge, experience with complex multifunctional systems
Ability to facilitate cross-functional team meetings.
Strong written and oral communications skills using English language; ability to succinctly and clearly describe complex issues in meaningful ways.
Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts.
Proactive and timely in execution of assigned tasks
Ability to be flexible and adaptable to changing priorities
Welch Allyn is a division of Hill-Rom, a $2.8B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.
Hill-Rom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity
Additional Salary Information: Competitive base salary plus 10% target bonus
Internal Number: 18124809
About Welch Allyn
Welch Allyn is a global manufacturer of medical diagnostic devices located in Skaneateles Falls, New York, and is part of Hill-Rom, a medical technology company. Welch Allyn is a worldwide company with offices in North America, Latin America, Europe, Middle East, Africa, Asia and the Pacific Rim whose mission is to empower clinicians and health systems with smarter tools to assess, diagnose and treat patients with confidence.