Responsibilities

We are looking for a Senior Mechanical Engineerwith a strong engineering and problem resolution background to implement product improvements to our core technologies for laboratory instruments. You will work on sustaining engineering projects in all stages, from root cause analysis and problem resolution definition to design through implementation and performance monitoring. The goal is to excel in product support, customer focused design and manufacturing acoustics-based laboratory instruments.

Our instruments are complex systems with electromechanical, fluidic, thermal, optical, and acoustic sub-systems. Our plastic consumables are engineered for high performance in harsh acoustic environments. Fabrication methods range from machining to injection molding, depending on the components' functional requirements. Our product portfolio also featureshardware accessories to increase the level of laboratory automation for workflow solutions that include our AFA instruments.

You will be the primary point engineer for the sustaining projects working with other engineers from manufacturing and quality departments tomanage implementation of solution-based designsinto the manufacturing environment. Responsibilities include analysis, planning, designingand testing to ensure solutions meet functional and performance requirements for our customers. This is predominantly an on-site position in Woburn, MA.Occasional remote work is OK with supervisor approval.

Responsibilities:

• Work as technical leadon cross-functional teams to isolate challenges and identify opportunities to improve design and manufacturing of sophisticated ultrasound-based instrumentation and HW accessories for laboratory automation.

• Use root cause analysis techniques to isolate issues and identify solutions for improving workflow, cost, manufacturability, performance or address individual customer needs as they arise.

• Use SolidWorks to design and document mechanical components and assemblies for instrumentation and HW accessories.

• Develop physical and functional testing along with calculation, tolerance analyses andsimulation (FEA, CFD), toensure that the product design meets all requirements (functional, cost, ergonomic, material compatibility, etc).

• Create DOEs and test plans and execute them to generate data for solution implementation evaluation and verification of problem resolution.

• Hold cross-functional reviews, document design solutions, test plans, verification reports, and other supporting documentation needed to fulfill process and change-order requirements.

• Work with the manufacturing team in managing external vendors to ensure high-quality, reproducible components delivered to design specifications.

• Work closely with the quality assurance department to ensure print specifications are inspectable and provide support on quality inspection procedures; update prints as needed to reflect design intent in a manner that is measurable, repeatable and controlled

• Execute change orders in our eQMS system.

• Prepare reports and presentations for different levels (engineers to executive management).

• Assess recommended design, test and process solutions for added or residual risk per risk management controls procedures using FMEA

• Ensure designs align with applicable ANSI, ASME, and SBS standards.

Qualifications

• A bachelor's Degree in Mechanical Engineering or equivalent with 5+ years of product support experience or a BS and MS in Mechanical Engineering with 3+ years of experience.

• Sketch-based CAD modeling experience in PLM / database file management systems.

Preferred Qualifications:

• Familiarity with mechanical drawing best practices using ASME & ANSI standards.

• Experience with CAPA management and workflow

• Experience with GD&T and tolerance analysis for assemblies and interfaces.

• Experience with mid-high complexity electromechanical assemblies.

• Experience with Quality Control processes and familiarity with ISO 9001.

• Experience with precision machined parts, molded parts, ceramic components, etc.

• Expertise with Microsoft Office - Word, Excel, PowerPoint, Teams, Outlook.

• Experience w/ risk management including dFMEA, pFMEA, DOE, DFM.

• Excellent communication skills - written, verbal, and presentation skills.

• Experience with management of regulated products (FDA Class II / IVD instrument preferred) and familiarity with ISO 13485, etc.