Your responsibilities will include:
- Fully participate in project teams to contribute the necessary technical work related to product design and development.
- Mentor junior engineers and provide technical leadership within the project team, fostering a collaborative and innovative environment.
- Collaborate closely with manufacturing, process engineering, supplier engineering, and customer support teams to ensure seamless product development.
- Gather requirements from internal and external sources to accurately capture user needs and ensure products are meeting them.
- Perform in-depth technical analysis, root cause investigations, and failure mode assessments for both new and existing products.
- Generate and review detailed engineering documentation (e.g. technical reports, DHF, DMR) and ensure compliance with quality systems and regulatory requirements.
- Drive and support Design for Manufacturing (DFM) activities, identifying opportunities for process optimization and cost reduction.
- Ensure compliance with company health and safety policies and proactively address unsafe working conditions.
- Other duties as required, including leading continuous improvement initiatives.
Required qualifications:
- Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering or equivalent
- Minimum 5 years related working experience, or equivalent
- Proven track record of leading product development projects from concept to market release, with strong expertise in regulatory compliance and quality management systems (e.g. 21 CFR 820, ISO 13485).
- Experience working within a quality management system and expertise in generating and reviewing engineering documentation (e.g. technical reports, DHF, DMR), in compliance with design controls
- Ability to work independently and within a diverse group of Engineers
- Strong communication skills (verbal/written) with the ability to present technical data to cross-functional teams and external stakeholders.
Preferred qualifications:
- Master’s degree in Biomedical, Mechanical, or Electrical Engineering preferred
- Extensive experience in medical device R&D, with a focus on prototyping, testing, and development of catheter devices
- Expertise in industry standards and regulations (e.g. ISO, ASTM, ASME, IEC, etc.) and their application in medical device design and development
- Experience with product lifecycle management
- Experience with injection molding component design
- Experience with electrical medical device testing and development
Compensation forhourly, non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
salaried, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation foris governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).