Mechanical Engineer

******* LOCAL CANDIDATES TO WORK LOCATION OR OPEN TO RELOCATE**** NO C2C*******

Job Title: Mechanical Engineer 

Location: Burlington, MA (100% ON-SITE)

ID# SEDAA 46673 

PAY RANGE:  100K - 110K/Annum

About Client

The Opportunity

Our Heart Failure R&D team is seeking a Senior Mechanical Engineer to provide technical leadership and hands-on expertise in the development of Mechanical Circulatory Support devices, specifically Left Ventricular Assist Devices (LVAD). This role is ideal for an engineer passionate about solving complex problems in life-sustaining technologies and driving innovation in mechanical and electromechanical systems.

You will work cross-functionally to design, analyze, prototype, and test implantable Class III devices, contributing to the full product lifecycle from concept through commercialization.

Top 3 Skills 

• Test method development and execution specifically with in INSTRON or similar compression/tension tester
• CAD design and drawing skills including GD&T
• Product development experience for medical device

What You'll Work On

• Specify, design, verify, and validate mechanical components and subsystems for LVADs in accordance with regulatory and quality standards.
• Apply empirical, numerical, and experimental analysis (FEA, CFD, etc.) to evaluate and optimize designs for performance, reliability, and manufacturability.
• Develop and execute test methods and simulation models to mitigate design risks and ensure product robustness.
• Lead design reviews, risk assessments, and documentation efforts including CAD models, specifications, and technical reports.
• Collaborate with cross-functional teams including systems, electrical, software, clinical, and manufacturing engineering.
• Interface with suppliers and internal teams to source prototype and production components.
• Mentor junior engineers and contribute to a culture of technical excellence and continuous improvement.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering or related STEM field.
• 6+ years of experience in mechanical design and development, preferably in the medical device industry.
• Proficiency in SolidWorks or equivalent CAD software and FEA tools (e.g., COMSOL).
• Strong understanding of materials, manufacturing processes, and design for reliability.
• Demonstrated ability to lead technical projects and deliver results in a regulated environment.
• Excellent communication and documentation skills.

Preferred Qualifications

• Experience with Class III implantable devices or cardiovascular technologies.
• Familiarity with FDA regulations, EUMDR, ISO 13485, ISO 14971 design controls and regulatory requirements.
• Exposure to computational modeling, fluid dynamics, and hemocompatibility testing.
• Experience with cable design, electromechanical integration, and biocompatible materials.

******* LOCAL CANDIDATES TO WORK LOCATION OR OPEN TO RELOCATE**** NO C2C*******

Job Title: Mechanical Engineer 

Location: Pleasanton, CA (100% ON-SITE)

ID# SEDAA 43086
PAY RANGE:  50K - 90K/Annum

Description: 

Performs complex activities in the testing and sustaining of class II and class III mechanical circulatory support products including Ventricular Assist Devices (VADs), extracorporeal blood pumps, and oxygenators. Provides technical solutions to a wide range of difficult problems. Exercises considerable latitude in determining technical objectives and solutions of assignments.

RESPONSIBILITIES:

• Research, test, and sustain electromechanical devices for VAD applications
• Work with cross-functional teams for development of new products, and improvement to existing products driven by corrective and preventative actions (CAPA)
• Use experimental, empirical, and numerical analysis to evaluate designs.
• Develop and qualify (IQ/OQ) fixtures/equipment for verification testing
• Investigate issues and identify root causes in complex systems where analysis of situations or data requires an in-depth evaluation of various factors
• Identify and mitigate technical risks
• Create/review technical drawings for appropriate assembly, dimensioning, and tolerancing
• Knowledgeable in GD&T
• Able to review/create tolerance analysis of existing systems
• Understands complex machined parts, injection molded parts, extrusions, molding of silicone
• Wide range of assembly techniques (laser welding, ultrasonic welding, bonding, mechanical joining)
• Experience with risk management FMEA’s
• Aid in vendor evaluations such as manufacturing capability and capacity, engineering support, and quality controls
• Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

MINIMUM QUALIFICATIONS:

• B.S. in Mechanical, Biomedical, or Manufacturing Engineering.
• 8+ years engineering experience including product development, process development, risk assessment, and V&V verification related to class II/III medical devices
• Industry experience with FDA design controls 21 CFR 820.30
• Strong communication and presentation skills (e.g. versatility communicating with peers, management, auditors/regulators, and customers)
•  Ability to travel approximately 10%, primarily in the US, but may include international)

PREFERRED QUALIFICATIONS:

• Design and V&V of class II/III electromechanical medical devices, such as VADs, extracorporeal blood pumps, oxygenators, or other implantable devices
• Experience with medium to high volume medical device manufacturing
• Experience with a variety of manufacturing processes and designing for manufacturability Industry experience with EU MDR, ISO 13485, and standards for medical devices (e.g. biocompatibility, sterilization, labeling, packaging, etc.)
• Experience with CAD design, SPC/six sigma, DOE, and project management

******* LOCAL CANDIDATES TO WORK LOCATION (Atlanta, GA )OR OPEN TO RELOCATE**** NO C2C*******

Job Title: Supplier Development Quality Engineer

Location: Atlanta, GA  (100% ON-SITE)

ID# SEDAA 42869

PAY RANGE:  50K - 85K/Annum

Description: 

• Must have engineering degree – prefer Mechanical but any engineering degree will work. 
• Must have 3-6 year of work experience with at least one year of supplier quality engineer experience.
• 100% onsite. Relocation at own expense is okay if the relocation process is fairly quick but prefer local.

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier. 
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures. 
• Develops and/or sources inspection tools and equipment. 
• Assists in generating component specifications. 
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products. 
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.;
• Analyzes incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers. 
• Reviews new design specifications and provides input from component quality and manufacturability perspective. 
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. May lead a project team of moderate scope. Provides guidance to less experienced staff. 
• BS degree in engineering field plus 3-6 years of related work experience with a good understanding of specified functional area.