Lead Process Engineer, Diagnostics Manufacturing

Mainerafting; Scarborough (ME); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

Education benefit

Strong employer recognition

Job summary

Abbott Rapid Diagnostics in Scarborough, Maine, seeks an Engineering Supervisor Process Engineering to lead a team of engineers and technicians supporting diagnostic product manufacturing. You will drive capital planning, process improvements, and equipment qualification to ensure compliant, state-of-the-art processes.

The role requires FDA/ISO knowledge, Lean/Six Sigma experience, and strong leadership within a regulated environment. Join Abbott to advance health and patient outcomes worldwide.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) required.
• 5+ years of experience in manufacturing/process engineering within a regulated industry (medical device, pharma, or biotech).
• Demonstrated knowledge of FDA regulations, ISO 13485, GMP, and quality system requirements.
• Proven leadership or supervisory experience, including managing or mentoring engineers/technicians and driving team performance.
• Experience with process validation (IQ/OQ/TMV/PQ), equipment qualification, material qualifications, and continuous improvement methodologies (Lean, Six Sigma).

Responsibilities

• Lead and develop a team of process engineers and technicians to support daily manufacturing operations.
• Set priorities, monitor performance, and align with production goals and quality standards.
• Coach, mentor, and develop the team’s skills and capabilities.
• Oversee design, control, and improvement of manufacturing processes for diagnostic product production.
• Ensure processes are robust, repeatable, and compliant with regulatory requirements.
• Collaborate with Quality and Operations to maintain compliance and efficiency.
• Drive process validation and equipment qualification activities including IQ/OQ/PQ.
• Maintain documentation and data integrity in SOPs and engineering records.

Skills

Leadership

Team Development

Problem Solving

Data Analysis

Communication

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ

Equipment qualification

DOE methods

Job description

Abbott Rapid Diagnostics in Scarborough, Maine, seeks an Engineering Supervisor Process Engineering to lead a team of engineers and technicians supporting diagnostic product manufacturing. You will drive capital planning, process improvements, and equipment qualification to ensure compliant, state-of-the-art processes.

The role requires FDA/ISO knowledge, Lean/Six Sigma experience, and strong leadership within a regulated environment. Join Abbott to advance health and patient outcomes worldwide.