Senior Manufacturing Engineer - Medical Devices
Senior Manufacturing Engineer - Medical Devices
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Job Description
Are you ready to collaborate with worldclass innovators and bring cuttingedge medical research to life Join our clients Boston Incubation Center where we transform groundbreaking medical innovations into meaningful lifeenhancing products. We are seeking a Senior Manufacturing Engineer with a passion for excellence in manufacturing particularly in cart systems console operations and electromechanical devices.
In this role you will bridge the gap between R&D pilot and commercial manufacturing teams contributing from early human use through to the commercialization of new products. Using your technical expertise youll ensure processes are robust scalable and compliant leveraging methodologies such as LEAN Six Sigma Design for Manufacturing (DFM) and Design for Cost (DFC).
Key Responsibilities
What Youll Do
- Develop and optimize costeffective validated manufacturing processes for medical devices focusing on capital and disposable devices (assembly testing sterilization packaging).
- Produce productionlevel assembly and part drawings for components and subassemblies using SolidWorks.
- Incorporate DFM Six Sigma and LEAN principles to ensure manufacturability reduce costs and optimize production efficiency.
- Identify and evaluate contract manufacturing partners for quality cost delivery and regulatory compliance.
- Serve as a liaison between the client and Contract Manufacturing Organizations (CMOs) to coordinate manufacturing activities.
- Validate manufacturing processes by conducting experiments analyzing results and developing detailed reports.
- Lead pFMEA development process validations and risk mitigation strategies.
- Create and maintain critical manufacturing documentation including BOMs work instructions and travelers.
What Youll Deliver
- Robust validated manufacturing processes aligned with project goals.
- Comprehensive task lists for DFM activities.
- Uptodate accurate BOMs pFMEA and work instructions.
Qualifications
MustHave Skills
- Bachelors degree or higher in Mechanical Engineering.
- 5 years of medical device manufacturing experience including at least 3 years in new product development and process validation.
- Handson expertise in cart systems console operations and electromechanical devices with proficiency in troubleshooting and optimizing these systems.
- Advanced proficiency in SolidWorks (assemblies tool/fixture design).
- Experience collaborating with contract manufacturers particularly in capital equipment and catheter manufacturing.
- Strong background in DFM Six Sigma LEAN cGMP and process validation methodologies.
- Proficient in statistical software such as Minitab or JMP for process monitoring and improvement.
NicetoHave Skills
- Certification in LEAN and/or Six Sigma.
- Familiarity with sterilizable polymers and catheter fabrication techniques.
Employment Type
Full Time
