Your responsibilities will include:
- Fully participating in project teams to contribute the necessary technical work related to packaging and product design and development
- Technical analysis of medical device packaging systems and materials for new product development and existing products to ensure designs meet quality and regulatory standards
- Gather requirements from internal and external sources to accurately capture user needs and ensure products are meeting them
- Investigate field related issues and perform root cause analysis
- Generate engineering documentation (e.g., DHF and DMR) in adherence to quality policies and systems.
- May lead packaging specific initiatives to support new designs, materials, or process related issues.
- Adhere to all requirements of the Quality Management System
- Other duties as required
Required qualifications:
- Bachelor’s degree in engineering
- 4+ years of related work experience
- Experience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.)
- Strong analytical and problem-solving abilities
- Strong oral and written communication skills, to communicate with individuals at various levels
Preferred qualifications:
- Bachelor’s degree in mechanical or biomedical engineering strongly preferred
- Experience working within medical device R&D departments, with hands-on prototyping and testing
- Experience using CAD software (e.g., SolidWorks)
- Knowledge of packaging materials including paperboard, corrugate, flexible packaging films, Tyvek, thermoformed trays, and manufacturing methods.
- Familiarity with industry related standards (e.g. ISO, ASTM, etc.) and their direct application
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).