Manufacturing Engineer II
POSITION SUMMARY:
This position will design, develop, and implement manufacturing processes and equipment to support existing commercial products and products in development. Processes and equipment may be located within Antares or within contract manufacturer site.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- Collaborate on device designs to ensure manufacturability
- Translate device design requirements into process and equipment requirements that meet Regulatory and Quality requirements
- Collaborate on risk management activities including user and design FMEAs
- Lead the development and documentation of process FMEAs to identify/reduce risk
- Develop, execute, and document equipment qualifications and process validations, including master validation plans/reports and IQ, OQ, PQ plans/repo1ts.
- Utilize tools including measurement system analysis (MSA), gage repeatability and reproducibility (GRR), design of experiments (DOE), statistical process control (SPC), and capability analysis to develop, troubleshoot, and control processes
- Support test method and inspection method development/validation used during design verification, process validation, and commercial manufacturing
- Develop, implement, and support production documentation including manufacturing procedures, routers, and bill of materials (BOM)
- Utilize tools including value stream mapping, overall equipment effectiveness (OEE), and SS to understand and improve quality, labor efficiency, throughput, and cycle time
- Provide engineering support to customers, equipment suppliers, and contract manufacturers
- Develop project timelines, scope of work, and other project documents to ensure cross-functional/cross- company alignment and project success
- Provide project communication to team members, customers, contract manufacturers, and stakeholders
- Support product complaint investigations and reports
- Support CAP A/NCR/SCAR investigations and reports
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Bachelor level degree in Engineering or related Science
YEARS OF EXPERIENCE:
-
3-7 years relevant experience within the medical device, pharmaceutical, or related industry
OTHER SKILLS AND ABILITIES:
- Experience with medical device or pharmaceutical product manufacturing
- Experience with plastic injection molding processes and high-volume metal forming processes
- Experience with manual, semi-automated, and fully automated assembly processes
- Experience with equipment specifications
- Experience with manufacturing process instructions
- Excellent written skills including technical protocols/reports
- Ability to communicate and educate internally and externally (product builders, cross-functional team members, suppliers, customers, stakeholders, regulatory agencies)
- Knowledge of GMP, CPR, ISO, QSR and other regulations, standards, directives, and guidance
- Experience with computer software including Minitab, Project, Excel/Word/Solidworks
- Experience with statistical tools, data analysis, and Six Sigma
- Ability to solve problems, troubleshoot, and improve processes and equipment
- Ability to manage multiple projects
- Ability to work independently or in cross-functional team environment
- Travel up to 30% (domestic & international)