Sr Mfg Eng - Medical Device Project Eng

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

 

In this newly created role as a Manufacturing Engineering Value Stream (VS) Lead in West SOC you will have responsibility for overseeing the development and implementation of manufacturing processes to maintain proper product functionality as well as cost efficiency. Ensures the engineering team and other manufacturing departments work together cohesively for the development of equipment to aid in the manufacturing process.

The ideal candidate for this role will have a strong understanding of the CAPA process, excellent problem-solving skills, and strong communication and presentation skills. Candidate should have experience working with and getting alignment with a variety of functional support groups to accomplish improvements. We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes. Manage interns or groups of junior engineers on day-to-day tasks such as testing, reporting, drafting, and analysis work

Please note this role does work on-site.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

 

Responsibilities may include the following and other duties may be assigned.

 

• Reviews, evaluates, and implements engineering changes and specification requirements. S/he will be responsible for leading the sustaining and project activities of the value stream either directly or through a team of engineers and technicians (about 5-8) driving continuous improvements, responding to NCR’s, ownership of CAPA’s, complaints and work instructions while executing and supporting capacity improvement capital projects and line transfers
• Performs equipment qualifications (IQ), process validations (Process characterization, OQ and PQ), and gage R&R studies (TMV). Applies statistical methods and science-based decisions to design experiments and implement improvements
• Monitor, identify root cause and resolve process yield issues.
• Provides technical and sustaining engineering support in a manufacturing area. Troubleshoots and resolves equipment/process production issues. Takes ownership for yield, productivity, uptime, and work instructions.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Generates and maintains documentation per quality system regulations Ensures processes and procedures follow regulation
• Drives solutions to systemic issues through CAPA process.
• Collaborates with partners in Operations, Quality, and Development to drive improvements.
• Responsibilities may include the following and other duties may be assigned.

 

Required Qualifications: 

• Bachelor’s degree required in Mech/Industrial/Electrical Engineering or other Eng discipline
• Minimum of 7-10 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
• Regulatory compliance in cGMP manufacturing and/or extensive manufacturing knowledge of Pharmaceutical or Medical Device Products.
• Strong background in Process Validation, FMEA’s, DOE’s, development of VMP’s and experience in audits from Regulatory Agencies
• Hands-on problem solver with solid knowledge of structured problem-solving processes such as DMAIC, 8D and/or 5 Whys
• Knowledge of statistical analysis tools such as Minitab.

 

Preferred Qualifications:

• Six Sigma Green Belt or Black Belt Certification a plus!
• Excellent written and verbal communication skills