Impel is a virtual manufacturing company — all manufacture and supply is outsourced to suppliers. This position provides outstanding customer service to Impel’s combination product development programs by ensuring timely and technically rigorous implementation of new designs into manufacture at Impel’s Contract Manufacturing Organization(s) (CMO) and component suppliers. The Sr Manufacturing Engineer leads the technical coordination, development, and review of manufacturing related activities. This role is responsible for the manufacturing technical transfer of design into clinical and commercial manufacture as well as supporting existing manufacturing capabilities. Specific focus on injection molding, semi-automated, and automated assembly lines.
The ideal candidate has a positive attitude, is flexible, organized, multi-tasks, collaborative, can deal with ever changing priorities, and enjoys learning new ways to provide value to the organization. The Sr Manufacturing Engineer delivers high quality processes and products to program deadlines.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
· Owns technical manufacturing development within Impel’s project team
· Acts as point of contact for manufacturing related issues. Leads internal and external team efforts to resolve manufacturing issues through application of experience, technical knowledge and skill.
· Defines and manages Impel’s approach to manufacture and scale up including appropriate use of resources to achieve product target timeline and cost
· Manages supplier development of manufacturing tooling and equipment ranging from low volume manual manufacture to high volume automated manufacture and packaging
· Owns manufacturing improvement process – track metrics, propose improvements, execute or manage implementation
· Acts as conduit between Impel and virtual contract manufacturing lines – provides internal reporting to Impel teams
· Develop Impel’s metric tracking tools to focus efforts where they bring the most value
· Evaluates technical capability and contributes to the CMO selection process.
· Develops Impel’s manufacturing capacity to support manufacture of Impel product, clinical through commercialization.
· Supports project teams by participating in the planning, maintenance, and development of new, modified and/or existing manufacturing activities conducted at CMOs.
· Maintains adherence to medical device quality standards and regulations, with emphasis on CMC activities.
· Works closely with the Quality Assurance group to ensure that manufacturing operations at Impel’s CMOs are in control and are appropriately monitored.
· Ensures thorough and adequate PFMEAs are developed for all respective processes
· Identifies and mitigates risks associated with manufacturing processes
· Plans and defines design transfer requirements in accordance with 21 CFR 820 for combination products
· Supports manufacturing process validations
· Keep key stakeholders apprised of impending manufacturing activities and challenges
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s degree is required.
- Minimum 5 years of experience as a Manufacturing Engineer, Assembly Process Engineer, and/or Plastics Tooling Engineer in a fast paced, multi-project, progressive environment
- Must be proficient in Microsoft Office products, Proficiency with Microsoft Project or Smartsheet is a plus.
- Outstanding communication skills
- Working knowledge of standard manufacturing metrics and methodologies – SPC, OEE, lean, six sigma, etc.
- Positive team player, willing to step in and fill identified project team gaps
- Must be capable of continuous learning and have a desire to take on an ever-changing list of tasks.
- Thorough grasp of tool qualification, process validation, process control and FDA 21 CFR 820 manufacturing requirements.
- Previous experience with contract manufacturing
- Experience in regulated environment – medical, aerospace, nuclear
- History of both implementing new manufacturing lines and supporting legacy lines
- Lean manufacturing implementation
- Solidworks or other parametric solid modeling capability
Must be capable of lifting packages under 50 lbs. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines