Senior R&D Manufacturing Engineer, High-Throughput

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 116,600 - 177,800; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision coverage

Paid time off and holidays

Job summary

Meso Scale Diagnostics LLC (MSD) is seeking an experienced leader to drive R&D of high-volume manufacturing methods for diagnostic consumables. You will guide scalable design, develop prototypes, and collaborate with internal teams to scale processes from research to production.

Ideal candidates have a strong background in high-throughput manufacturing and regulatory-compliance experience, with a track record in biologics production and cGMP environments.

Qualifications

• Bachelor’s degree in biology, chemistry, biotech, engineering or related field.
• Master’s degree in a similar field preferred.
• Minimum 10 years in high-throughput plastic manufacturing.
• Minimum 5 years manufacturing biological products preferred.
• Experience with cGMP and/or ISO certifications preferred.

Responsibilities

• Lead a multidisciplinary R&D team for high-volume consumables manufacturing.
• Guide scalable, high-quality consumable design processes.
• Develop prototypes for consumable manufacturing and inspection.
• Make key technical decisions during R&D activities.
• Hands-on work in active experimental programs.
• Prepare designs and technical reports for projects.
• Create/update manufacturing and project documents and procedures.
• Collaborate with Quality to meet guidelines.
• Ensure compliance with regulatory standards.

Skills

Roll-to-Roll processing

Sheet-to-sheet processing

Plastic film processing

Bonding techniques

Forming techniques

Coating techniques

Biological handling

Project leadership

Regulatory compliance

Analytical thinking

Education

Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering

Master’s degree preferred

Tools

cGMP

ISO certification

Job description

Meso Scale Diagnostics LLC (MSD) is seeking an experienced leader to drive R&D of high-volume manufacturing methods for diagnostic consumables. You will guide scalable design, develop prototypes, and collaborate with internal teams to scale processes from research to production.

Ideal candidates have a strong background in high-throughput manufacturing and regulatory-compliance experience, with a track record in biologics production and cGMP environments.