Senior Engineer, NPD Quality

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 108,000 - 153,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking a Senior Engineer, NPD Quality to join our New Product Development Quality team, ensuring products meet regulatory and quality standards throughout development.

You will partner with Manufacturing, Clinical, Regulatory, and R&D to drive design controls, risk management, verification and validation, and process improvements, delivering patient-focused solutions.

Qualifications

• Bachelor's degree in Engineering or a Scientific field with 4+ years of related experience, or Master's degree with 3+ years of related experience.
• Ability to document and maintain design control documentation throughout product development.
• Familiarity with regulatory requirements for medical device product development.

Responsibilities

• Apply quality engineering principles to ensure regulatory compliance and Edwards procedures for new product development.
• Develop and maintain design control documentation and design requirements.
• Maintain risk management and usability documentation.
• Collaborate with R&D, Manufacturing, and cross-functional teams to drive process and test method development, design transfer, and product launches.
• Investigate complex quality and compliance issues (CAPA, non-conformances, audits) during development and report findings.
• Identify opportunities to optimize manufacturing and R&D processes using Six Sigma or Lean methods.

Skills

Documentation skills

Communication skills

Leadership

Problem-solving

Cross-functional teamwork

Time management

Education

Bachelor's degree in Engineering or Science

Master's degree or equivalent

Tools

MS Office Suite

MS Project

CAD

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

Our Senior Engineer, NPD Quality, position is a unique career opportunity that could be your next step toward an exciting future. Imagine how your ideas and expertise can change a patient's life. Our New Product Development Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross-functionally with Manufacturing, Clinical, Regulatory, and R&D teams, delivering thoughtful solutions to complex challenges while expanding your knowledge of the medical device industry.

Responsibilities

• Applying knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures for new product development.
• Developing, updating, and maintaining design control documentation throughout the product development process; supporting the creation of design requirement documentation.
• Developing, updating, and maintaining the technical content of risk management and usability files.
• Collaborating with R&D, Manufacturing, and other cross-functional stakeholders to drive process and/or test method development, product builds, clinical programs, design transfer, and product launch; participating in design verification and validation testing.
• Investigating complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyzing results, making recommendations, and developing reports.
• Identifying and ensuring the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma, Lean) to support design for manufacturing and continuous process improvement; identifying opportunities for the design or redesign of equipment, tools, fixtures, and related components to improve manufacturing processes and/or test methods and reduce risk.
• Assigning support tasks and providing instruction to technicians on conducting tests; training technicians and providing feedback; coordinating technician work as needed; and training, coaching, and guiding lower-level employees on routine procedures.
• Performing other incidental duties as assigned.

What You'll Need (Required)

• Bachelor's degree in Engineering or a Scientific field and 4 years of related industry experience; OR Master's degree or equivalent in Engineering or a Scientific field and 3 years of related industry or industry/education experience

What Else We Look For (Preferred)

• Proven expertise using the MS Office Suite, including MS Project; CAD experience preferred (if applicable).
• Strong documentation, communication (written and verbal), and interpersonal relationship skills, including consultative and relationship management skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment (if applicable).
• Substantial understanding and knowledge of engineering principles, theories, and concepts relevant to the role.
• Strong problem-solving, organizational, analytical, and critical-thinking skills.
• Substantial understanding of the processes and equipment used in assigned work.
• Good leadership skills and the ability to influence change.
• Knowledge of applicable FDA regulations for the medical device industry.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work effectively in a team environment, including inter-departmental teams, and to serve as a key contact representing the organization on contracts or projects.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Benefits & Compensation

• competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
• For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Equal Opportunity Statement

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.