Senior Mechanical Engineer

BioTalent; Boston; On-site; GBP 80,000 - 90,000; Full time

Job summary

A leading company in the medical equipment manufacturing sector seeks a Medical Device Engineering & Manufacturing Consultant. In this role, you will enhance the design and manufacturability of ultrasound-driven lab automation instruments. The ideal candidate will have a Bachelor's in Mechanical Engineering and significant hands-on experience in product development. Join a collaborative team to drive efficiency and innovation in the manufacturing process.

Qualifications

• Bachelor’s degree in Mechanical Engineering (or equivalent) with a minimum of 5 years supporting product development.
• Experience with CAD modeling, particularly in PLM-managed environments.
• Background with regulatory environments, especially Class II FDA or IVD products.

Responsibilities

• Primary technical contributor on interdisciplinary teams for advanced ultrasound-driven lab automation.
• Troubleshoot technical problems using structured methods.
• Collaborate with production teams to ensure design standards.

Skills

SolidWorks

Geometric Dimensioning and Tolerancing (GD&T)

Communication

Risk analysis tools

Education

Bachelor’s degree in Mechanical Engineering

Tools

Microsoft Office Suite

Job description

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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