Senior Staff Engineer Medical Devices & Regulated Systems

SoTalent; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

SoTalent seeks a Senior Staff Engineer in Lexington, MA to lead design, testing, and oversight of medical devices and combination products in a regulated environment.

You will mentor engineers, oversee validation, and coordinate with Quality, Regulatory Affairs, and external partners to ensure safety, reliability, and performance across programs.

The role offers autonomy and influence over industry concepts and standards within a fast-paced, compliant setting.

Qualifications

• BS in Mechanical, Chemical, Biomedical, or Materials Engineering with 8+ years experience (6 years with MS or PhD).
• Regulated development of combination products under ISO 13485/ISO 14791 and 21 CFR 820 Design Controls.
• Experience in injection molding, product design, and statistical evaluations.
• Ability to author and review complex technical reports and regulatory submissions (BLA/NDA/MAA).
• Excellent communication with stakeholders across business units; influence skills.
• Experience with test system validation and Design for Six Sigma is preferred.

Responsibilities

• Oversee engineering operations for medical devices from development to commercialization.
• Lead mechanical tasks: CAD fixture design in SolidWorks, 3D printing, CT data analysis.
• Create and maintain technical docs, protocols, and guidance for standardization.
• Validate test methods and equipment per GxP and international regulations.
• Collaborate with Quality, Regulatory Affairs, and Drug Product Development on qualification strategies.
• Manage relationships with CROs/CMOs; support investigations of deviations.
• Mentor junior staff to foster growth and technical excellence.

Skills

Regulated device development

Design Controls & regulatory

Statistical evaluations

Technical report writing

Stakeholder influence

Six Sigma/DFSS exposure

Education

Bachelor of Science in Mechanical, Chemical, Biomedical, or Materials Engineering

Master's degree with 6+ years of experience

PhD (optional)

Tools

SolidWorks

3D printing

CT scan data analysis

Job description

SoTalent seeks a Senior Staff Engineer in Lexington, MA to lead design, testing, and oversight of medical devices and combination products in a regulated environment.

You will mentor engineers, oversee validation, and coordinate with Quality, Regulatory Affairs, and external partners to ensure safety, reliability, and performance across programs.

The role offers autonomy and influence over industry concepts and standards within a fast-paced, compliant setting.