Mechanical Engineer II

LanceSoft Inc; Franklin Lakes (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading medical device company in New Jersey seeks a skilled product design/development engineer with 3-8 years of experience, particularly in high-volume manufacturing. Responsibilities include supporting the design portfolio, ensuring quality compliance, and participating in technical projects. The ideal candidate should have a B.S. in Mechanical Engineering and proficiency in Pro-E or SolidWorks.

Qualifications

• 3 to 8 years of experience in the medical device or pharmaceutical industries.
• Demonstrated experience with all phases of the Design Control process.
• Proficient in product development processes and safety regulations.

Responsibilities

• Support design and development activities for the product portfolio.
• Participate in technical project work and propose innovative solutions.
• Ensure compliance with quality policies and local regulations.

Skills

Design for high-volume manufacturing

Communication skills

Interpersonal skills

Team orientation

Education

B.S. Mechanical Engineering

Tools

Pro-E

SolidWorks

Job description

Experience: 3 to 8 years of experience as a product design / development engineer in the medical device or pharmaceutical industries Experience with designing for high-volume manufacturing methods such as molding and stamping, and automated assembly and packaging processes Experience with designing metal and plastic components. Demonstrated experience with all phases of the Design Control process: implementing product changes through a structured, phase-gated, product development process. Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes Clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ. Proficiency with Pro-E or Sold Works. Strong technical skills and judgment. Good communication skills. Team Orientation Strong interpersonal and influence skills. Strong motivational fit. Familiarity with project planning skills and leadership methods. Understanding of disciplined product development processes, regulatory and quality requirements.

Responsibilities:

This position is within the R&D organization of Client Medical. This position will contribute to design and development activities focused on identifying, developing and implementing solutions to support the current and future product portfolio. More specifically, the job responsibilities will include: Support design and development activities for products within the product portfolio. Support products in terms of design, quality, manufacturing, supply continuity and cost improvement. Participate in executing technical and/or cross-functional project work. Contribute to innovation by proactively generating Client concepts to improve current product performance or enhance products' ability to address customer needs. Need to provide solid technical skill and is responsible for solving technical problems. May have to develop creative and Client solutions to technical problems. Perform and Plan assigned product development activities. Set priorities for self and contribute to team planning. Ensure compliance with Client quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. Ensure compliance with all local, state, federal, and Client safety regulations, policies, and procedures. Accountable for success of assigned tasks and project deliverables. Participate in and lead periodic design reviews of projects. Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities. Develop understanding of customer needs and processes to ensure relevant and innovative product development solutions. Develop and demonstrate interpersonal influence and persuasion skills. Inclusive work environment: Promote and leverage diversity to achieve best outcomes. Ensure all interested parties have opportunities to influence and contribute to decisions and outcomes. Dealing with ambiguity; Demonstrate agility and action orientation when facing change and uncertainty.

Qualifications

B.S. Mechanical Engineer, Bachelor's Degree

Additional Information

• 3-D Cad Modeling
• Ability To Work Individually & With The Team Can Work On Multiple Project At A Similar Time