Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – to enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Our work in specialty diagnostics – from providing diagnostic assays and instruments to clinical monitoring across disease stages – improves the diagnosis and management of blood cancers and immune system disorders. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

The Binding Site, part of Thermo Fisher Scientific, is a global leader in specialty diagnostics that provides diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Site Freelite® offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. In addition, The Binding Site is an active and influential contributor to the broader scientific community. To find out more visit https://www.thermofisher.com/bindingsite.

Position Summary:

In the role of Electromechanical Engineer II, you are accountable for the design, construction, and assessment of electromechanical systems and components for medical devices. Your tasks will involve collaborating closely with different teams and external partners to ensure that our products meet customer specifications and align with quality and regulatory requirements. You will lead projects of moderate complexity, coordinate EMC evaluations, drive supplier modifications, and provide technical assistance throughout the product life cycle.

Responsibilities:

Development:

• Create and implement electromechanical designs and improvements, integrating motors, sensors, actuators, and control systems.
• Develop detailed engineering drawings, schematics, and specifications for electromechanical components and systems.
• Conduct feasibility studies and prototype testing to validate development concepts.
• Collaborate with software, hardware, and systems engineers to ensure the reliable integration of electromechanical components.
• Work together with external collaborators and contracted groups to complete development assignments, guaranteeing they match project objectives and requirements.
• Participate in risk management activities, including hazard analysis and failure mode effects analysis (FMEA).

Testing and Validation:

• Develop and implement test plans to validate the performance, reliability, and safety of the products.
• Perform root cause analysis and solving of electromechanical issues.
• Document test results and provide recommendations for improving development.
• Coordinate Electromagnetic Compatibility (EMC) testing to ensure compliance with relevant standards and regulations.
• Review EMC test outcomes and incorporate adjustments to resolve any issues.
• Ensure that electromechanical compositions align with applicable regulatory standards (e.g., FDA, ISO 13485).

Supplier Coordination:

• Coordinate supplier changes, including assessing the impact of changes on electromechanical systems.
• Conduct assessments on modifications implemented by suppliers to ensure ongoing consistency with quality/regulatory standards.
• Collaborate with suppliers to implement modifications and ensure integration into existing systems.

Project Management:

• Lead and implement engineering projects, ensuring timely delivery and alignment to specifications.
• Report progress and issues to senior team members and management.

Collaboration:

• Collaborate with interdisciplinary teams, such as software engineers, hardware engineers, quality assurance, and regulatory affairs, to guarantee project triumph.
• Deliver technical aid and instruction to manufacturing and service teams.
• Coordinate external partners and outsourced teams to ensure successful project finalization.

Documentation:

• Maintain detailed documentation of all build, development, testing, and validation activities.
• Ensure traceability of verification activities to requirements and risk management documentation.

Minimum Requirements/Qualifications:

Education:

• Bachelor’s degree in Electromechanical Engineering, Mechanical Engineering, Electrical Engineering, or a closely related field or applicable experience is required

Experience:

• 3+ years of experience with positive outcome in a related field.
• Knowledge of regulatory standards and guidelines relevant to medical devices (Preferred).

Knowledge, Skills, Abilities:

• Proficiency in advancements in electromechanical systems.
• Experience with CAD software (e.g., SolidWorks, AutoCAD).
• Ability to diagnose and resolve electromechanical issues.
• Experience with EMC testing and mitigation techniques.
• Good verbal and written communication skills, able to clearly explain technical details to non-technical collaborators.
• Ability to adapt to changing technologies and methodologies in a fast-paced environment.

Physical Requirements / Work Environment:

• Mixture of office and laboratory work.
• Infrequent light lifting (<10kg).
• Potential infrequent travel (1-2 times per year).