Senior NPD Engineer

JOB SUMMARY

The Senior NPD Engineer provides technical leadership for development programs throughout the NPD lifecycle. Acting as the technical lead, the role is responsible for engineering execution, technical decision-making, ensuring products are developed in accordance with customer, regulatory, quality, and manufacturing requirements.

The Senior NPD Engineer serves as the primary technical interface with customers, leading technical discussions, design reviews, and problem-solving activities. Working in partnership with the Program Manager, the role contributes to project planning, budgeting, resource allocation, and risk management while maintaining accountability for technical project outcomes.

The role provides leadership, coaching, and mentoring to engineers and technicians and may have direct people management responsibility. The successful candidate will combine strong product development expertise with the ability to lead multidisciplinary teams and build strong customer relationships in a dynamic, fast-paced environment.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

• Lead the technical execution of product development programs from feasibility through manufacturing transfer.
• Act as the primary technical interface with customers, building strong relationships and providing technical leadership throughout the development process.
• Lead technical reviews, design reviews, risk assessments, and problem-solving activities with customers and internal teams.
• Own technical strategy, design decisions, and engineering execution for assigned projects.
• Ensure products and associated processes are developed in accordance with customer requirements, Design Controls, regulatory standards, and business objectives.
• Partner with Program Managers on project planning, budgeting, resource allocation, risk management, and successful project execution.
• Provide technical input into project budgets and ensure engineering activities are executed within agreed project constraints.
• Identify, assess, and mitigate technical risks throughout the product development lifecycle.
• Ensure compliance with company procedures, Quality System requirements, and applicable regulatory standards.
• Drive development activities through verification, validation, design transfer, and commercialization.
• Collaborate with Customers, and internal stakeholders (Manufacturing, Quality, Supply Chain) to achieve successful project outcomes.
• Support manufacturing scale-up, product transfer, and post-commercialisation activities.
• Support feasibility studies, rapid prototyping activities, and technology development initiatives.
• Provide leadership, coaching, and technical guidance to engineers and technicians and may have direct people management responsibility.
• Promote a culture of technical excellence, accountability, collaboration, and continuous improvement.
• Maintain accurate technical documentation and development records throughout all stages of product development.

EDUCATION & EXPERIENCE REQUIREMENTS

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or a related discipline.
• Minimum 7 years of medical device product development experience.
• Demonstrated experience leading development projects throughout product development lifecycle.
• Experience working within Design Control and regulated medical device environments.
• Proven customer-facing experience with responsibility for technical discussions and project leadership.
• Experience leading, mentoring, or managing engineers and technical teams.
• Experience with catheter-based, balloon catheter, or delivery system technologies is an advantage.

SKILLS & ABILITIES

• Strong medical device product development experience.
• Working knowledge of Design Controls, Risk Management, Verification & Validation, and Design Transfer.
• Knowledge of applicable medical device regulations and standards, including ISO 13485 and FDA requirements.
• Strong customer relationship and stakeholder management skills.
• Excellent technical, communication, presentation, and problem-solving skills.
• Ability to lead cross-functional teams and influence stakeholders.
• Understanding of project planning, budgeting, and resource management principles.
• High level of integrity, professionalism, and accountability.
• Strong organizational skills and attention to detail.
• Demonstrated ability to coach and develop technical talent.

WORKING CONDITIONS & PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to look at a computer screen, reports and other documents. The employee is regularly required to use their hands on a computer keyboard or a calculator. The employee is regularly required to sit, talk, hear and interact with other employees. The employee is regularly required to stand and walk.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Statement

Quasar Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.