Product Line Lead

About the role

The Product Line Leader will manufacture, supervise and coordinate production of quality medical device products that meet acceptance criteria. This position ensures the solid execution of company programs remains consistent with overall company values. The ideal candidate has a solid understanding of manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Responsibilities

• Supervise manufacturing team responsible for production of assigned products.
• Assist in the manufacturing of products in accordance with Batch Records and Standard Operating Procedures (SOPs).
• Ensure quality records, including logbooks, procedures, training records, etc., are completed.
• Implement process improvements with emphasis on quality, safety and cost reduction.
• Monitor and control production costs.
• Oversee the transfer of manufacturing processes from R&D to commercial launch.
• Develop and implement validation protocols and master plans.
• Enforce cGMPs, safety regulations and environmental requirements.
• Ensure assigned personnel are effectively trained in their job requirements.
• Investigate quality issues and prepare investigation reports (CARs).
• Write and revise Batch Records and Standard Operating Procedures (SOPs).
• Prepare and track required GMP documents (ECOs, Process Deviations, Product Dispositions).
• Maintain adequate inventory to prevent backorders and excessive production costs.
• Prepare Annual Product reports and Quarterly trending.
• Initiate action to prevent the occurrence of nonconformities.
• Organize equipment files and meet preventive maintenance and calibration deadlines.
• Maintain supplies and requisition as needed.
• Perform performance management for all assigned personnel.
• Interview and select new hires for assigned teams.
• Assist with various special ad hoc projects and other duties as assigned.

Competencies

• Meaningful Innovation
• Ownership/Accountability
• Pace/Efficiency
• Teamwork/Collaboration
• Integrity/Ethical Practice
• Resilience/Grit

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Supervisory Responsibilities

This position manages manufacturing technicians and assistants staff and projects.

Education, Experience and Certification

• Minimum of a GED/high school diploma with four (4) years of medical device or pharmaceutical manufacturing experience, or a Bachelor’s degree in engineering or sciences with 2 years medical device or pharmaceutical manufacturing experience.
• Experience with Microsoft software applications (Word, Excel, PowerPoint).
• Ability to perform detailed document review.
• Ability to work in a team environment.
• Strong organizational skills and ability to simultaneously track multiple projects.
• Excellent communication skills (oral and written).

Benefits

• Company performance bonus eligibility
• 401(k) plan with company contribution
• Paid time off and paid holidays
• Medical, prescription, dental, and vision insurance
• Company-paid life and AD&D insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Pay

$28–$32 per hour