Sr. Mechanical Engineer - Product Development at Softworld Inc

Job Title: Sr. Mechanical Engineer

Location: Andover MA 01810

Onsite Requirements:

• Injection Molding
• Product Development
• Medical Device

Job Description:

ESSENTIAL TASKS/ DUTIES INCLUDE:

• Responsible for CAD design, building, and testing of new concepts and iterating through the design process.
• Provide direction to engineers, technicians, external industrial design teams, and OEM manufacturers.
• Work closely with manufacturing engineering and apply DFM techniques to ensure product is capable of being assembled and tested using automation.
• Perform thorough analysis (tolerance, dFMEA, DOE, statistical) to ensure product will meet design requirements.
• Manage injection mold suppliers through the tool development process and ensure conformance to specifications.
• Develop drawings and release documentation in accordance with applicable standards and SOPs.
• Assist V&V testing with protocols, reports, fixtures, and TMVs.
• Maintain DHF including design reviews, reports, meeting minutes, etc.
• Perform other development tasks and duties as required.
  

BACKGROUND AND QUALIFICATIONS:

• 8 years of product development experience as mechanical design engineer with 3 years in a lead role for complex Class II or III disposables and electromechanical medical equipment.
• Expert in Solidworks 3D modeling and design. 3D surfacing expertise desired.
• Experienced in design of injection molded disposables and plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bonding.
• Some experience in design of electromechanical sub-systems including machined/sheet metal components and motorized assemblies.
• Solid foundation of mechanical engineering fundamentals and ability to perform engineering analysis including tolerance analysis, GD&T, FEA, engineering 1st principles.
• Ability to work independently with some guidance.
• Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems.
• Hands-on skills and ability to use power tools and light machine shop equipment required.
• Strong written and verbal communication skills are required.
• Understanding of medical device development processes including experience with FDA CFR 820, ISO 13485, IEC 60601-1 regulations and standards.
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.
• Project management experience & Six Sigma Green Belt desired.
• Ability to be onsite 5 days per week and lift 25lbs.
• 5% Domestic or International travel may be required.

EDUCATION:

• BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent is required.