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As a Manufacturing Engineering Director your responsibilities will include:

Lead and develop cross-functional engineering teams to drive

innovation, continuous improvement, and end-to-end manufacturing of medical devices from concept through production.

Ensure full compliance with FDA 21 CFR Part 820 cGMP, ISO 13485, and

related regulatory requirements across the manufacturing lifecycle, partnering closely with Quality and Regulatory.

Own manufacturing development and validation activities, including

design controls, risk management, testing, and process validation.

Drive operational excellence through lean manufacturing, automation,

and design-for-manufacturability initiatives to improve quality, scalability, cost, and efficiency.

Deliver projects on time and within budget while providing clear

communication to senior leadership, leading post-launch performance monitoring, and mentoring engineering talent.

The Manufacturing Engineering Director position may be right for you if you:

You thrive in leadership roles, guiding cross-functional engineering

teams to deliver innovative, continuously improving medical device manufacturing solutions from concept through production.

You bring deep regulatory and validation experience, confidently

ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and overseeing risk management, design controls, and testing.

You are energized by engineering improvement, driving lean

manufacturing, automation, and design-for-manufacturability to improve scalability, quality, and cost efficiency.

You excel at project leadership, balancing engineering rigor with

business needs while delivering projects on time, on budget, and with clear communication to senior stakeholders.

You take ownership beyond launch, leading post-production

performance monitoring, root cause analysis, and ongoing design and process enhancements.

You are passionate about people and collaboration, mentoring

engineers, fostering a culture of learning and innovation, and partnering closely with Quality and Regulatory teams to ensure alignment.

Have proven successful experience in capital expenditures and

automation investment projects.

.Qualified candidates will have:

Bachelors or masters degree in biomedical engineering, Mechanical

Engineering, Industrial Engineering, or a related field.

5+ years of experience with manufacturing processes, design for

manufacturability (DFM), and cost reduction strategies in the medical device industry.

At least 3 years of experience in the manufacturing of medical

devices and a strong understanding of FDA 21 CFR Part 820 cGMP, ISO 13485, and other applicable standards.

Experience with machine efficiency, down time, preventative

maintenance, calibrations, validation, QMS (Quality Management Systems) and regulatory adherence.

Energized and comfortable to work in 10% administration, 30%

leadership, and 60% hands-on in the plant environment.

Additional travel of 25% for training, vendor management or

leadership meetings is also required.\ \

Candidates must currently possess unrestricted authorization to work in the United States. Work visa sponsorship is not available for this role.

What will set you apart:

Technical, hands-on manufacturing experience expertise, validations,

design control/transfer.

Regulated medical industry experience and sustaining engineering

Experience with plating (not electroplating)

Experience with medical textile, R&D, design control, and qualityengineering.

Physical Requirements:

While performing the duties of this job, the employee is frequently required to sit, stand and walk to communicate and listen effectively. This will require both office and plant environments.

There is potential for a discretionary bonus, with a target of 10% This bonusis based onpersonal & company performance and is not a guaranteed bonus plan.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

Medical, Rx, Dental, Vision, Flexible Spending & Health Savings Accounts, EAP, Health Advocacy, Financial Planning, Parental Leave, Care.com, Group Life & AD&D, Voluntary Life Insurance, Short Term & Long Term Disability, 401(k) Plan with Company Match, PTO, Holidays & Leaves, Accident Insurance, Critical Illness Insurance, Hospital Indemnity, Pet Insurance, Identity Theft Protection, Long Term Care + Life Insurance.

You can find more on our Careers Website

BioDerm, Inc.

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