Senior Manufacturing Engineer
Job Location:
Ventura, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
The Senior Manufacturing Engineer leads and coordinates the fabrication installation operation maintenance and repair of mechanical and electromechanical manufacturing systems. The position ensures quality and industry standards are consistently met or improved while driving efficiency evaluating equipment performance and cost-effectiveness and recommending design or process modifications to enhance reliability and reduce malfunctions. This is an onsite role in Ventura California.
What You Will Do
- Design develop and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product lines
- Develop and maintain process FMEAs control plans and work instructions
- Lead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformances
- Apply Lean and Six Sigma methodologies to reduce defects cycle time and manufacturing costs
- Partner with R&D to ensure design-for-manufacturability (DFM) during new product development and Design Transfer activities
- Collaboration with Regulatory Affairs and Quality on technical files
- Define equipment specifications; lead procurement installation and commissioning of manufacturing equipment
- Maintain calibration and preventive maintenance programs for production equipment
- Ensure manufacturing documentation (DHR DMR batch records) is complete accurate and inspection-ready
- Support internal customer and regulatory audits (FDA Notified Body); prepare responses to audit findings
- Maintain compliance with FDA ISO 13485 and ISO 14971 requirements
What You Need
- Bachelors degree in Mechanical engineering Biomedical Engineering Industrial Engineering or related discipline
- Minimum 5 years of engineering experience in a regulated medical device manufacturing environment
- Hands-on experience with process validation (IQ/OQ/PQ) and Design Transfer
- Working knowledge of ISO 13485 quality management systems
- Proficiency with statistical analysis and process capability tools (e.g. Cpk Gage R&R)
- Experience authoring engineering documentation including SOPs work instructions and validation protocols
Preferred
- Masters degree in Engineering (Mechanical Biomedical Industrial or related field)
- Six Sigma Green Belt or Black Belt certification
- Experience supporting Class II or Class III medical devices
- Familiarity with ISO 14971 risk management and FMEA methodologies
- Proficiency with CAD tools (e.g. SolidWorks) and ERP/MES systems
- Experience supporting FDA inspections or Notified Body audits
- Knowledge of sterilization methods (EtO gamma e-beam) or cleanroom manufacturing
United States of America Pay Ranges:
- US10: $ 85500.00 - 142500.00 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:
Senior IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
