Massachusetts Green Jobs

OVERVIEW Dynamic and early-stage medical device company is searching for an energetic and self-motivated individual to drive forward product development. Specific emphasis will be given to those applicants interested in a challenging opportunity with immense impact and who flourish in a fast-paced environment. As a member of the engineering design and development team, the preferred candidate will problem solve and participate in the specification, design, build and testing of a diverse range of medical disposables and instruments. RESPONSIBILITIES -Utilize SolidWorks for mechanical design. -Design test fixtures based on R&D, manufacturing, and quality requirements. -Assemble and test mechanical components for improving instrument functionality. -Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements using both internal and external technical resources. -Maintain and periodically update engineering SOPs under document control to satisfy ISO 9001, ISO 13485, and other national and international regulations and standards. -Perform routine calibration on instruments and verify conformance. -Contribute to risk assessment of mechanical and system design, including generation of FMEAs -Participate in corrective and preventive action (CAPA) meetings and follow through on actionable items. -Prepare and release design documentation to support release to manufacturing for new prototypes, and provide support for existing prototypes transferred to production -Work with internal and external organizations as required developing instrument improvements -Create and review technical drawings for appropriate dimensions and tolerances for the application. -Partner with internal and outsourced manufacturing to develop effective fabrication, in-process control, and final quality test procedures. -Propose and implement modifications to improve performance of manufacturing process of medical disposables and instrument components. -Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and postproduction GMP compliance in coordination with the Document Control functions. -Create and maintain bill of materials. -Aid in the selection, evaluation and ramp up of contract manufacturers. QUALIFICATIONS/ COMPETENCIES: -Ability to create, design and solve engineering problems with minimal assistance. -Demonstrated ability to breakdown problems into actionable task lists. -Familiarity with basic machine shop equipment and metrology tools. -Proficient in Solidworks design, ANSI drafting practices and Geometric Dimensioning and Tolerancing (GD&T). -Hands-on experience with testing procedures to verify analytical results. -Knowledge of manufacturing processes such as CNC machining, injection molding, extrusion, 3D printing, preferred. -Methodical, evidence-based approach to technical problem solving. -Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources. -Hands-on prototyping skills with mechanical, electro-mechanical and electronic assemblies. -Capable of working on projects both independently and as a part of a team. -Bachelor?s degree minimum in Mechanical, Electromechanical, Biomedical, Instrumentation Engineering or related engineering field with 0-5 years of experience. -Demonstrated proficiency in MS Office applications and SolidWorks. -Excellent English written and verbal communication skills. -Familiarity with class II/III medical device, 21 CFR 820.30, FDA 510(k) preferred, but not required. Job Type: Full-time Benefits: -401(k) -Dental insurance -Health insurance -Paid time off Schedule: -8 hour shift -Monday to Friday Ability to commute/relocate: -Boxborough, MA 01719: Reliably commute or planning to relocate before starting work (Required) Work Location: In person