Senior Staff Engineer

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

Our client is a global leader in the pharmaceutical sector, dedicated to advancing patient care through innovative medical devices and combination products. We are seeking an experienced Senior Staff Engineer to join their team in Lexington. This role is ideal for a technical leader who enjoys solving complex engineering challenges and mentoring others within a regulated environment.

As a key member of the engineering team, you will act as a consultant to management and an external representative for major technical matters. You will lead the design, testing, and operational oversight of medical equipment, ensuring all products meet the highest standards for safety, performance, and reliability. This position offers a high degree of autonomy and the opportunity to influence the development of new industry concepts and standards.

Key Responsibilities

• Oversee engineering operations for medical devices and combination products from development through commercialization.
• Lead advanced mechanical engineering tasks, including CAD fixture design using SolidWorks, 3D printing, and CT scan data analysis.
• Create and maintain technical documentation, protocols, and guidance to ensure standardization and high quality across all programs.
• Manage the validation of test methods and equipment in compliance with GxP and international medical device regulations.
• Collaborate with cross functional teams, including Quality, Regulatory Affairs, and Drug Product Development, to align on device qualification strategies.
• Supervise relationships with external partners such as CROs and CMOs, providing technical support and investigating root causes for deviations.
• Mentor junior staff members to foster professional growth and technical excellence within the department.

Required Qualifications

• Bachelor of Science in Mechanical, Chemical, Biomedical, or Materials Engineering with at least 8 years of industry experience. Candidates with a Master degree and 6 years of experience or a PhD are also encouraged to apply.
• Strong background in the development of regulated combination products under ISO 13485, ISO 14791, and 21 CFR 820 Design Controls.
• Expertise in injection molding, product design, and statistical evaluations.
• Demonstrated ability to author and review complex technical reports and regulatory submission documents for BLA, NDA, or MAA filings.
• Exceptional communication skills and the ability to influence stakeholders across different business units.
• Experience with test system validation and Design for Six Sigma certification is highly preferred.

Working Conditions

This role requires working in controlled manufacturing environments which may involve specific gowning procedures, protective equipment, and occasional exposure to cold or wet conditions. Applicants should be flexible regarding shift schedules if needed to support project milestones.

Compensation

The estimated base salary range for this position is 137,000 to 215,270 USD annually. Final offers are determined based on the candidates specific experience, educational background, and technical certifications. Our client also offers a comprehensive benefits package.

Our client is an equal opportunity employer committed to a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or any other protected characteristic.