Your responsibilities include:
- Fully participate in project teams to contribute the necessary technical work related to product design and development.
- Technical analysis of medical device systems and materials for existing products to ensure designs meet quality and regulatory standards.
- Assist in DFM (Design for Manufacturing) activities and work cross-functionally with Quality, Sourcing and Process/Manufacturing counterparts.
- Investigate failure modes and perform root cause analyses
- Generate detailed engineering documentation (e.g. Technical reports, DHF, and DMR) in adherence to quality policies and systems.
- Conducts planning for broad, technical projects by applying mature engineering knowledge, and soliciting input from other stakeholders as appropriate.
- Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
- Other duties as required.
Required qualifications:
- Bachelor’s degree in Mechanical/Biomedical engineering, or equivalent
- Minimum of 4 years related working experience, or equivalent
- Experience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.)
- Experience with design requirements for medical devices as per 21 CFR 820 and ISO 13485.
- Knowledge of medical device risk management and ISO 14971.
- Candidates should be self-starters and have a hands-on approach
- Ability to work independently and within a diverse group of Engineers
- Strong communication skills (verbal/written)
Preferred qualifications:
- Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering preferred
- Experience working within medical device industry
- Familiarity with industry-related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their direct application
- Experience with product lifecycle management
- Experience with catheter devices development
- Experience with injection molding component design
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).