Sr. Manufacturing Engineer
Summary and Scope of Position:
As a Senior Manufacturing Engineer, this person will collaborate with contract manufacturers to understand, improve, and control operational processes in order to realize predictable product flow for the manufacture of single-use medical devices for the Class III INTERCEPT Blood System for Platelets and Plasma. This person will ensure excellent standards of manufacturability, yield improvement, cost reduction/scale, complex mechanical fixture design and test, automation, failure analysis, and advanced process controls are established. Successful performance requires close working relationship with contract manufacturers and/or Cerus colleagues to assure compliance with all Cerus quality policies, procedures, and practices.
- Lead post-commercialization product/process changes, assembly line optimization, production expansion activities, and cost-saving initiatives at contract manufacturers. Work with contract manufacturers and vendors to prioritize and solve issues and support continuous improvement.
- Support new manufacturing validations and design transfer for new products, as needed.
- Support tech transfer between facilities.
- Define and execute design verification studies and validation plans, including both hands-on laboratory experiments and manufacturing studies.
- Manage manufacturing issues by utilizing failure analysis, troubleshooting, root cause analysis and problem-solving techniques.
- Work with Quality Assurance and Operations teams to identify, correct, and prevent product quality issues.
- Analyze risk using current FMEAs and similar tools.
- Support process and design improvements for future products based on key learnings from sustaining programs.
- Participate on Cerus cross-functional teams and provide updates as needed.
- Release new or revise existing documentation into the Cerus Document Control System.
- Support resolution of customer complaints for disposables.
- Author or review portions of IDEs, Regulatory Change Notifications, and/or Design Dossiers, as needed.
- Lead Design Reviews and create or maintain project specific Design/Change History files, as needed.
- Bachelors or Master’s degree in chemical, mechanical, or biomedical engineering with minimum 5 years of medical device/IVD disposables manufacturing experience.
- Demonstrated initiative and inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
- Experience in PFMEA, Gauge R&R, Process Validation and Process Capability for process designs
- Experience in Failure Analysis/Ishikawa methodology
- Knowledge of lean and six-sigma manufacturing techniques.
- Demonstrated success in working with suppliers and contract manufacturers.
- Knowledge of QSR and Design Control requirements for medical devices is a must.
- Knowledge of GMP requirements for single-use medical device, including validation, testing, and sterilization requirements, aseptic manufacturing technique is a must.
- Expertise in flexible plastic containers, injection-molded components, and packaging systems is a must.
- Strong project management skills.
- Attention to detail and accuracy.
- Excellent communication skills (encompasses verbal, written, interpersonal, listening).
- Highly-motivated team player, flexible, ability to adapt to changing priorities.
Some domestic and international travel required (25-35%).