Sr. R&D Engineer - NPD

Job Summary:

As the Senior R&D Engineer, you'll spearhead the development of new products and oversee the evaluation and testing of existing ones across multiple product lines. Your role ensures that products meet quality standards and align with customer needs in terms of functionality and usability.

Duties and Responsibilities:

Lead the design and development of new products, ensuring adherence to design control processes and analyzing defects to enhance product quality and efficiency.

Conduct research and testing on product concepts, new developments, and existing products, making necessary material, design, and process changes.

Provide ongoing product support to manufacturing, sales, and quality teams, offering insights on design requirements, customer needs, and product documentation.

Direct the design and development of new products, applying engineering best practices and leading design analysis.

Collaborate with manufacturing to optimize designs for efficient and economical production.

Ensure compliance with ISO13485 standards, FDA regulations, and Good Manufacturing Practices throughout the product development process.

Lead technical design reviews and apply analytical methods such as DOE and statistical analysis to drive product improvements.

Mentor junior engineers, guiding them through activities like FMEA and design validation.

Develop test plans, approve prototypes, and maintain quality standards throughout the development process.

Create product literature by interpreting and explaining technical data and product performance.

Manage product projects from prototype to full production within established schedules and budgets.

Required Knowledge, Skills, and Abilities:

Proficiency in standard computer applications (MS Word, Excel, Outlook, PowerPoint).

Excellent communication skills for interactions with internal and external stakeholders.

Strong teamwork abilities, with a collaborative approach to problem-solving.

Attention to detail and ability to make decisions based on available resources and judgment.

Ability to maintain confidentiality and discretion.

Proactive problem-solving skills and ability to gather and analyze information effectively.

Willingness to learn and adapt to changes in the work environment.

Demonstrated leadership qualities, including trustworthiness and accountability.

Education and Experience:

Bachelor’s Degree in mechanical engineering, biomedical engineering, or a related discipline; Master’s degree or PhD preferred.

Design and development experience in the medical device or component industry (Aerospace, Aviation, Defense, or Oil and Gas)

Experience in high-volume manufacturing and assembly processes, particularly plastic injection molding.

Hands-on experience with Design Control, including verification and validation.

Familiarity with Phase-Gate development processes and rapid prototyping.

Proficiency in statistical methods and Six Sigma analysis.

Strong design skills, including proficiency in SolidWorks and understanding of CAE tools.