Job Description

Job Description

Title: Manufacturing Manager - Production

Location: Baltimore, MD 21230 (Onsite)

Duration: Full-Time, Permanent

Job Description:

Terms of Employment

• Full-Time, Permanent
• This position is fully onsite in Baltimore, MD 21230 – Monday-Friday, normal business hours. Occasional evening or weekend work may be required to support production schedules.

Position Summary

• A fast-paced medical device startup is seeking a hands-on, energetic, and resourceful Manufacturing Manager to build its production capabilities from the ground up. This is not a traditional management role focused on delegation; we are looking for a "roll-up-your-sleeves" leader who will be instrumental in establishing and scaling a GMP manufacturing line. The ideal candidate will have a strong engineering background and thrive in a dynamic environment where they can wear multiple hats, directly troubleshoot problems on the line, and drive progress with limited resources. You will be responsible for the manufacturing of both diagnostic cartridges and instruments, making a direct impact on the company's success.

You will…

• Take the lead in standing up a GMP manufacturing line from scratch. This includes identifying and filling operational gaps, developing and implementing manufacturing procedures, and ensuring the line is prepared for and compliant with regulatory standards.
• Directly manage the day-to-day manufacturing of IVD cartridges and instruments, including processes involving molded plastic components. When the line stops, you are the first to investigate the problem and determine a path to resolution, whether it's an in-house fix or managing a vendor for an urgent response.
• Oversee the training and development of a small, growing manufacturing team, fostering a culture of ownership, safety, and operational excellence.
• Ensure all manufacturing activities adhere to GMP, ISO 13485, and FDA QSR (21 CFR Part 820) requirements. Author batch records and work instructions, lead investigations into deviations, and implement CAPAs.
• Serve as a key point of contact for the manufacturing department during FDA audits and other regulatory inspections, leveraging your strong communication skills and process knowledge.

Qualifications & Experience (The Must-Haves)

• A Bachelor’s degree in an Engineering discipline (e.g., Mechanical, Electrical, Biomedical, Industrial) is strongly preferred. Degrees in life sciences (Biology, Chemistry, etc.) will also be considered if accompanied by significant relevant engineering experience.
• 3-7 years of manufacturing experience in the medical device or IVD industry. We are flexible on years of management experience; candidates with at least one year in a leadership role (e.g., supervisor, lead, or senior engineer) who possess the right character and drive are encouraged to apply.
• Core Competencies:
• Demonstrated, hands-on experience establishing, validating, or significantly improving a GMP manufacturing line.
• Strong background in medical device manufacturing processes, including experience with molded plastic components and automated assembly.
• In-depth knowledge of quality and regulatory standards, including ISO 13485 and FDA QSR.

The Ideal Candidate Profile (Who You Are)

• You are not afraid to "get your hands dirty". You are naturally curious and take the initiative to troubleshoot issues directly before delegating.
• You have the confidence and maturity to navigate challenges and get things done in an environment that doesn't have a large, established support structure.
• You thrive in a small-company environment where you will wear multiple hats and adapt quickly to changing priorities.
• You are a confident and mature professional. We believe the right personality is critical and can help overcome minor technical deficiencies.
• You possess excellent communication skills, with the ability to clearly articulate issues and collaborate effectively across functions. Experience facing an FDA audit is a significant plus.

Sincerely,

Preetam Raj

Lead Technical Recruiter

nTech Workforce Inc

D: 410-505-4857 EXT: 726

E: preetam@ntechworkforce.com

preetam(at)ntechworkforce(dot)com

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