Direct message the job poster from BioTalent
Medical Device Engineering & Manufacturing Consultant
Responsibilities:
* Serve as the primary technical contributor on interdisciplinary teams focused on enhancing the design and manufacturability of advanced ultrasound-driven lab automation instruments and hardware accessories.
* Apply structured root cause analysis methods to troubleshoot technical problems and propose improvements for efficiency, cost reduction, performance optimization, and custom client solutions.
* Utilize SolidWorks to develop and document detailed mechanical parts and complete assemblies for both instruments and supporting hardware.
* Perform engineering analyses including physical testing, tolerance stack-ups, and simulations such as FEA and CFD to validate that designs align with all functional, ergonomic, material compatibility, and budgetary requirements.
* Design experiments (DOE), develop testing protocols, and execute validation efforts to gather data supporting resolution strategies and verify improvements.
* Facilitate cross-disciplinary design reviews, maintain thorough documentation for design iterations, test procedures, validation results, and ensure alignment with engineering change management processes.
* Collaborate with production teams and external suppliers to guarantee delivery of consistent, high-quality components that meet design standards.
* Partner with quality assurance personnel to confirm that drawings are inspection-ready, refine specifications, and implement print revisions that ensure repeatability and clarity of design intent.
* Administer change control activities using the organization’s electronic Quality Management System (eQMS).
Qualifications:
* Bachelor’s degree in Mechanical Engineering (or equivalent) with a minimum of 5 years supporting product development, or a combination of BS and MS with at least 3 years of relevant experience.
* Skilled in CAD modeling within PLM-managed environments, with strong familiarity in sketch-driven design.
* Deep understanding of industry standards for mechanical drafting, particularly ASME and ANSI.
* Hands-on experience with CAPA processes and associated workflows.
* Proficient in Geometric Dimensioning and Tolerancing (GD&T) and tolerance evaluations at the assembly and interface level.
* Experience working with electromechanical assemblies of moderate to high complexity.
* Familiarity with quality systems including ISO 9001 and related manufacturing standards.
* Background in components requiring tight tolerances such as machined, molded, or ceramic parts.
* Adept in Microsoft Office Suite including Word, Excel, PowerPoint, Teams, and Outlook.
* Experienced in risk analysis tools such as dFMEA, pFMEA, DOE, and Design for Manufacturability (DFM).
* Strong communication skills for documentation, verbal discussion, and presentation contexts.
* Prior exposure to regulatory environments, ideally with Class II FDA or IVD products and ISO 13485 compliance.
* Willingness to travel up to 10% for vendor meetings or industry events.
Preferred Skills:
* Knowledge of 3D printing methods and familiarity with standard commercial printing platforms.
* Advanced proficiency in SolidWorks and use of its Product Data Management (PDM) system.
* Comfort with simulation tools embedded in SolidWorks, including FEA and CFD.
* Background in life sciences or biopharma, including biological workflows.
* Hands-on experience with robotic or motorized multi-axis systems for microplate handling and laboratory automation.
* Demonstrated ability to resolve technical issues using logical, structured approaches.
* Understanding of mechanical properties of materials and processes like surface finishing or plating.
* Scripting or programming experience (Python or similar) is a plus.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Industries
Medical Equipment Manufacturing
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