Senior Program Manager, Medical Devices & Regulatory

MissionStaff; Malvern (Chester County); On-site; USD 130,000 - 170,000; Full time

Job summary

MissionStaff is seeking a Sr Program Manager to lead engineering and cross-functional teams through the entire product development lifecycle for regulated medical device programs. The role requires coordinating hardware and software efforts, managing risk, and ensuring milestones meet quality and regulatory standards.

You should have deep knowledge of product development processes and regulations (FDA QSR, GMP, ISO 60601/13485/14971), strong communication, and a history of delivering complex

Qualifications

• Knowledge of product development processes and dependencies.
• Familiarity with FDA QSR, GMP, and ISO regulations (60601, 13485, 14971).
• Strong communication and problem-solving skills; Six Sigma certification preferred.

Responsibilities

• Lead engineering and cross-functional teams through the full product lifecycle.
• Drive on-time, on-budget delivery with high quality and regulatory compliance.

Skills

Product development

Regulatory knowledge

Cross-functional leadership

Embedded & cloud software

Communication & problem solving

Education

Bachelor of Science in Engineering

Job description

MissionStaff is seeking a Sr Program Manager to lead engineering and cross-functional teams through the entire product development lifecycle for regulated medical device programs. The role requires coordinating hardware and software efforts, managing risk, and ensuring milestones meet quality and regulatory standards.

You should have deep knowledge of product development processes and regulations (FDA QSR, GMP, ISO 60601/13485/14971), strong communication, and a history of delivering complex