Johnson Service Group is looking for a Manufacturing Engineer in the Bay Area, supporting one of our Contract Manufacturing Clients specializing in medical products. The ideal candidate will be responsible for supporting production floor activities, tracking the build process through the manufacturing cycle, and implementing new product layouts and manufacturing instructions. The role also includes driving continuous process and equipment improvements and implementing root cause corrective actions, ensuring compliance with stringent medical device manufacturing regulations.
Responsibilities:
Collaborate with the Program Manager on product or customer-related activities, including receiving and executing assigned tasks or project activities.
Interface with customers to understand medical product requirements, regulatory criteria, and ensure compliance with FDA and ISO 13485 standards to meet customer expectations.
Generate Pre- and Post-DfA/DfM analyses and reports for medical products (for example, using Valor or similar systems to create DfX reports). Recommend necessary engineering design changes to comply with medical device standards.
Review and approve New Product Introduction (NPI) preparation processes, including MPI, tooling, SAP production engineering modules, and medical product-specific documentation such as Device Master Records (DMRs).
Provide production floor support from pilot runs through mass production, including troubleshooting issues and guiding technicians and operators, ensuring compliance with Good Manufacturing Practices (GMP).
Develop, evaluate, and improve manufacturing and assembly processes for medical devices to ensure maximum productivity while maintaining regulatory compliance.
Perform data collection to drive continuous process improvements, equipment optimization, and corrective actions to address non-conformances in medical product manufacturing.
Implement cost reduction initiatives without compromising product quality or regulatory compliance.
Utilize lean manufacturing principles, ISO 13485 standards, and value stream mapping to improve production efficiency.
Design and implement production floor layouts to optimize workflow for medical device assembly.
Conduct TAKT time studies to ensure efficient production schedules.
Perform Design of Experiments (DOE) to validate manufacturing processes for medical products.
Review and analyze product yield, addressing any issues related to non-conformance in medical device manufacturing.
Support and lead root cause analysis for engineering issues related to medical device production, ensuring timely implementation of corrective and preventive actions (CAPA).
Develop and maintain process control plans and Process Failure Mode Effects Analysis (PFMEA) specific to medical product manufacturing.
Provide global support for manufacturing processes in other company facilities producing medical products.
Make capital equipment recommendations to improve medical device manufacturing processes.
Assist in the development of automated processes, ensuring compliance with medical device manufacturing regulations.
Prepare activity reports, process documentation, and input required data for regulatory audits and internal reviews.
Qualifications:
Seven (7) years of Manufacturing or Process Engineering experience in a contract manufacturing environment, with a focus on medical device manufacturing.
Bachelor’s degree in Engineering or a related field; equivalent experience will be considered.
Strong background in medical product documentation (e.g., Bill of Materials, Device Master Records, work instructions, product standards).
Experience in soldering processes and precision assembly for medical devices.
Expertise in creating Value Stream Maps and conducting ergonomic studies specific to medical product manufacturing environments.
Proficiency in CAM Software (e.g., CAM 350, AutoCAD, SolidWorks) and medical product development tools.
Strong problem-solving skills with a focus on FDA compliance, ISO 13485, and other regulatory standards.
Ability to read, analyze, and interpret schematics, technical procedures, and compliance reports for medical products.
Strong decision-making and leadership skills with demonstrated experience leading teams and projects in a regulated environment.
Experience with root cause analysis, problem-solving techniques, and project management in a medical product manufacturing context.
Familiarity with Quality Management Systems (ISO 13485), Lean Manufacturing principles, and customer satisfaction processes.
Proficient in MRP systems and the Microsoft Office Suite, including advanced knowledge of Excel for tracking production metrics.
Excellent organizational skills with the ability to multitask in a fast-paced, regulated environment.
Available to work flexible hours to meet production deadlines and regulatory commitments.
Rate starting at $110k, depending on experience
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
#D800
There are currently no related jobs. Please sign up for Job Alerts.
Loading...
Login to save this search and get notified of similar positions.
About Milpitas, CA
Looking to embark on a new career adventure? Dive into our job openings around Milpitas, California! Nestled in the heart of the Silicon Valley, Milpitas offers unparalleled growth opportunities for job seekers. With the stunning views of the nearby mountains, vibrant cultural scene, and access to top tech companies, this region is a dream for professionals looking to thrive. Take a stroll through the Great Mall for some shopping therapy, catch a show at the Milpitas theater, or recharge at Ed R. Levin County Park. Join us in exploring the dynamic job market in Milpitas and unlock a world of possibilities!
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.
