
Contract Manufacturing Lead Process Engineer – Indy Device Manufacturing
- Indianapolis, IN
- $64,500-167,200 per year
- Permanent
- Full-time
- Obtain technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, and critical process parameters for the process.
- Develop and provide training, technical oversight and mentorship to CMO process engineers.
- Provide program management support for CMO process engineers across multiple sites to evaluate reliability improvement projects, replicate across similar lines in the platform network and the shutdown management of those projects.
- Work with external companies and project teams to develop product and process improvements.
- Evaluate scope and business cases for proposed capital improvement projects.
- Lead prioritization of process and product changes necessary to maintain, sustain and improve the manufacturing process.
- Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
- Support/lead the resolution of escalated manufacturing related issues, including deviations, investigations and evaluation of manufacturing data and supply chain coordination issues.
- Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues.
- Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
- Develop effective and productive working relationships with colleagues at CM sites.
- Define and mitigate technical and patient risks, including use of FMEA
- Minimum 3 years engineering experience in automated assembly equipment
- Root Cause Analysis, Investigation and Problem Solving skills
- Strong communication, teamwork, and networking skills
- Training, coaching and mentoring experience
- Proven ability to organize and prioritize multiple tasks
- Strong attention to detail
- Dry device assembly experience preferred
- Experience with DOE and statistical methods as applied to engineering studies and reports
- Experience in capital project delivery and project management scheduling and budgeting processes
- Experience working with 3rd party suppliers, specifically Original Equipment Manufacturers (OEM’s) and Contract Manufacturers (CM’s)