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R&D Engineer/Product Development Engineer
2 months ago
Key Responsibilities:
- Experimentation & Testing: Develop and execute moderately complex experiments and tests to improve product performance. Analyze results, make recommendations, and generate detailed reports based on engineering principles.
- Technical Documentation: Generate work instructions, test methods, engineering drawings, and prototypes to establish and characterize product and process specifications.
- Design Control Support: Create and update portions of design control documents, including requirement specifications and risk documents, ensuring compliance with regulatory standards.
- Technician Coordination: Assign tasks to R&D technicians, provide training, give feedback, and coordinate their work on testing and validation activities.
- Supplier Management: Identify, evaluate, and manage suppliers, establishing tolerances and defining acceptance criteria for products and services.
- Cross-Functional Collaboration: Collaborate with leadership and cross-functional teams to ensure alignment on product development, testing, and improvement projects.
- Compliance: Adhere to company policies and procedures, including Environmental Health & Safety (EHS) and Quality guidelines, ensuring all activities are compliant with industry standards.
Skills & Competencies:
- Technical Skills:
- Proficiency in MS Office Suite; CAD experience is preferred.
- Basic understanding of statistical techniques for data analysis and interpretation.
- Hands-on experience with lab/industrial equipment.
- Strong understanding of engineering principles, theories, and concepts relevant to product development.
- Problem-Solving & Analytical Skills:
- Solid problem-solving, organizational, and critical thinking skills with a focus on continuous improvement.
- Ability to manage multiple priorities in a fast-paced environment while maintaining attention to detail.
- Communication & Collaboration:
- Excellent documentation, verbal, and written communication skills, with the ability to interact professionally with all levels of the organization.
- Strong interpersonal and relationship management skills, with the ability to manage vendors and project stakeholders effectively.
- Ability to work collaboratively in a team environment and build productive internal and external working relationships.
- Regulatory & Safety Compliance:
- Familiarity with Edwards Environmental Health and Safety guidelines, clean room standards, and medical device manufacturing processes.
Education & Experience:
- Bachelor’s degree in Engineering (required).
- 2-4 years of relevant experience in product development, testing, and validation within the medical device industry or a similar regulated environment.
Additional Requirements:
- Strict adherence to company policies and procedures, including Environmental Health & Safety (EHS) rules and pandemic protocols.
- Ability to take proactive measures to ensure the protection of the environment and compliance with pollution prevention guidelines.
