Auf einen Blick
- Aufgaben: Lead engineering teams in the production and improvement of medical devices.
- Arbeitgeber: Join a leading company in medical device manufacturing focused on quality and innovation.
- Mitarbeitervorteile: Enjoy a collaborative culture, mentorship opportunities, and potential for travel.
- Warum dieser Job: Make a real impact in healthcare while developing your leadership skills in a dynamic environment.
- Gewünschte Qualifikationen: Bachelor’s or Master’s in Engineering with experience in medical device manufacturing required.
- Andere Informationen: Opportunity to work cross-functionally and drive sustainability initiatives.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
Job Description
POSITION SUMMARY:
The Director of Manufacturing Engineering will be responsible for leading engineering teams in the validation, production, and continuous improvement of medical devices. This position will ensure that all products meet regulatory standards, adhere to the highest quality controls, and align with the needs of both the business and customers. This position requires an expert in medical device manufacturing, with a strong track record of problem solving, project management, and leadership.
Essential Functions (ACCOUNTABILITIES/RESPONSIBILITIES):
- Leadership: Lead and manage cross-functional engineering teams in innovation and continuous improvement of the manufacturing of medical devices, from concept through to production.
- Validation: Ensure compliance with relevant regulatory standards, such as FDA 21 CFR Part 820 cGMP and ISO 13485 throughout the product manufacturing lifecycle. Oversee the development and execution of validation processes, including risk management, design control, and testing.
- Engineering Improvement: Drive the initiative for manufacturing development, including identifying emerging solutions to implement lean manufacturing and solutions to achieve business objectives. Improve manufacturing operations by optimizing designs for manufacturability, automation, scalability, and cost efficiency.
- Project Management: Ensure timely, cost-effective delivery of projects, balancing engineering best practices with the need for efficiency by working with internal and external teams. Provide regular status updates and clear communication with senior management regarding project timelines, budget, risks, and progress.
- Sustainability: Lead post-launch activities, including performance monitoring, root cause analysis, and design improvements.
- Team Development: Mentor and grow engineering talent, fostering a culture of collaboration, innovation, and continuous learning.
- Cross-Functional Collaboration: Work closely with regulatory and quality assurance to define clear product requirements and ensure alignment with standards.
Qualifications:
Experience:
- Proven 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 manufacturing processes, design for manufacturability (DFM), and cost reduction strategies in the medical device industry.
Education:
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
General Skills/Competencies/Specialized Knowledge:
- Proficiency in technical engineering and management tools including Microsoft Office, SolidWorks, and statistical analysis software (Minitab). The ability to lead teams through the complete manufacturing lifecycle, including design, validation, and sustainability. Strong problem-solving skills and experience with risk management processes (e.g., FMEA, hazard and root cause analysis).
- Excellent leadership and communication skills, with the ability to engage and motivate teams while working cross-functionally with other departments and stakeholders. Ability to prioritize and manage multiple projects in a fast-paced, dynamic environment.
TRAVEL REQUIREMENTS/WORK ENVIRONMENT and PHYSICAL DEMANDS:
Travel:
- Up to 25% may be required.
Work Environment and Physical Demands:
- The primary work environments will be in the office area and in the facility’s production areas.
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Director of Manufacturing Engineering Arbeitgeber: ZipRecruiter

Kontaktperson:
ZipRecruiter HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Director of Manufacturing Engineering
✨Tip Number 1
Make sure to highlight your experience in leading cross-functional teams. This role requires strong leadership skills, so be prepared to discuss specific examples of how you've successfully managed teams in the past.
✨Tip Number 2
Familiarize yourself with FDA regulations and ISO standards relevant to medical device manufacturing. Being able to speak knowledgeably about compliance will set you apart from other candidates.
✨Tip Number 3
Showcase your problem-solving abilities by preparing examples of challenges you've faced in manufacturing processes and how you overcame them. This will demonstrate your capability in driving engineering improvements.
✨Tip Number 4
Network with professionals in the medical device industry. Engaging with others in the field can provide insights and potentially lead to referrals that could help you land this position.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Director of Manufacturing Engineering
Tipps für deine Bewerbung 🫡
Tailor Your Resume: Make sure your resume highlights your experience in medical device manufacturing and project management. Use specific examples that demonstrate your leadership skills and familiarity with FDA regulations and ISO standards.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the medical device industry and detail how your background aligns with the responsibilities of the Director of Manufacturing Engineering role. Mention specific achievements that showcase your problem-solving abilities and team leadership.
Showcase Relevant Skills: Emphasize your proficiency in technical engineering tools and your experience with lean manufacturing processes. Highlight any certifications or training related to regulatory compliance and quality assurance that would be relevant to the position.
Prepare for Interviews: Be ready to discuss your previous projects in detail, particularly those that involved cross-functional collaboration and innovation in manufacturing. Prepare to answer questions about how you handle challenges in project management and team development.
Wie du dich auf ein Vorstellungsgespräch bei ZipRecruiter vorbereitest
✨Showcase Your Leadership Skills
As a Director of Manufacturing Engineering, your ability to lead cross-functional teams is crucial. Prepare examples from your past experiences where you successfully managed teams, drove innovation, and fostered collaboration.
✨Demonstrate Regulatory Knowledge
Be ready to discuss your understanding of FDA 21 CFR Part 820 cGMP and ISO 13485. Highlight specific instances where you ensured compliance in previous roles, as this will show your expertise in the medical device manufacturing field.
✨Emphasize Problem-Solving Abilities
Prepare to share detailed examples of how you've tackled complex problems in manufacturing processes. Discuss your experience with risk management techniques like FMEA and how they contributed to successful project outcomes.
✨Communicate Project Management Experience
Since project management is key for this role, be prepared to outline your approach to managing timelines, budgets, and resources. Share specific projects where you balanced engineering best practices with efficiency to achieve business objectives.