HYBRID - Senior Quality Engineer - Medical Device - Boston, MA

The Senior Quality Engineer role involves planning and executing quality assurance tasks and testing for new product development, collaborating with cross-functional teams, and conducting risk assessments and statistical analysis. Responsibilities also include material selection, process validation, and participation in design verification and validation testing.

Client Details

Our client is a leading innovator in the medical field, focusing on improving mobility for individuals with neurological disorders and upper-limb paralysis. They create and offer a range of advanced, lightweight, powered arm braces that help restore the use of arms and hands for people who have experienced strokes, spinal cord injuries, brachial plexus injuries, ALS, MS, and other similar conditions. These devices use non-invasive sensors to detect the user's neurological signals, enabling movement and helping individuals regain independence, return to work, and lower their care costs.

With a mission to foster independence and confidence for those with neurological challenges, our client is committed to advancing medical device technology and healthcare solutions, constantly pushing the limits of what is achievable in this field.

Description

• Engage in planning and executing quality assurance tasks and testing for new product development.
• Develop and qualify hands-on test procedures.
• Select and qualify materials for product development.
• Collaborate with development teams on POC and design assessments, including biocompatibility testing when necessary.
• Validate product specifications and oversee process validation activities.
• Participate in design verification and validation testing.
• Review and edit engineering protocols and reports.
• Conduct risk assessments, FMEA, and manage associated activities.
• Collect data and perform statistical analysis.
• Write detailed protocols and reports.
• Perform additional duties as assigned by the manager.

Profile

• Experience in medical device design and development processes.
• 3 to 5 years' experience as a Product Quality Engineer.
• Proven success as a member of a cross-functional team.
• Experience in electro-mechanical device development and testing.
• Bachelor's degree in Engineering or a related science field.
• Knowledge and experience with Quality Management Systems.
• Proficiency in conducting statistical analysis.
• Expertise in Quality Assurance applications and design control.
• Skilled in design assurance testing and test qualification.
• Familiarity with firmware and software program validation.
• Knowledge of reliability testing and analysis.

Job Offer

• Hybrid flexibility - candidates can work from home one day per week
• Competitive pay along with a comprehensive rewards package.
• Wide range of benefits and perks to enhance overall satisfaction and well-being.
• Emphasis on work-life balance with regular time off and flexible work arrangements, including hybrid or remote options.
• Supportive and collaborative team environment focused on professional growth and development.
• Opportunities for meaningful equity participation, promoting a sense of ownership and teamwork.
• Comprehensive health and wellness benefits for employees and their families.
• Commitment to community service with 8 hours of paid volunteering time annually.
  

Desired Skills and Experience

Experience in medical device design and development processes.
3 to 5 years' experience as a Product Quality Engineer.
Proven success as a member of a cross-functional team.
Experience in electro-mechanical device development and testing.
Bachelor's degree in Engineering or a related science field.
Knowledge and experience with Quality Management Systems.
Proficiency in conducting statistical analysis.
Expertise in Quality Assurance applications and design control.
Skilled in design assurance testing and test qualification.
Familiarity with firmware and software program validation.
Knowledge of reliability testing and analysis.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.