Job Title: Advanced Manufacturing Engineer
Overview:
The Advanced Manufacturing Engineer is a full-time position with responsibilities revolving around new product introduction and determining the most efficient processes for producing a high-quality product.
Reports To: Chief Operations Officer
Job Description:
The Advanced Manufacturing Engineer must:
· Design and develop manufacturing processes based on medical device design specifications, specifically catheters and other disposable medical devices.
· Develop and test effective semi-automated and manual manufacturing systems.
· Design and install equipment.
· Organize and manage Contract Manufacturers (CMOs).
· Conduct fixture design, development, and verification.
· Train CMOs in new and existing processes.
· Collaborate with R&D engineers, contractors, suppliers, and CMOs.
· Utilize innovative technology to create new processes to maximize efficiency and output.
· Create / Update Bill of Materials.
· Create / Update Cost Estimates based on annual production volumes.
· Identify and coordinate with suppliers for equipment sourcing.
· Develop complex experiments (including writing and executing protocols/reports) to qualify and validate manufacturing processes.
· Develop training and documentation materials (e.g., work instructions, travelers, manufacturing procedures) for production to enable knowledge transfer of product/process to CMO’s.
· Conducts testing to determine effectiveness and compliance to quality standards for the manufacturing processes.
· Recommend new tools and methodologies including cost estimates for design or production process enhancements.
· Develop technical documentation to specify manufacturing processes, including documentation of equipment qualification, setup, and maintenance procedures.
· Review engineering product specifications, CAD data/drawings, as part of the design review process to ensure they meet medical industry and manufacturing standards.
· Approve part/drawing releases, and confirm / structure Bill of Materials (BOM)
· Represent Operations in the Design Control Process.
· Manage inventory from incoming receiving through FGI inventory.
· Perform shipping function.
· Manage pilot production builds, planning, tracking, and execution.
Minimum Qualifications, Education and Experience Required:
· Bachelor’s Degree in manufacturing, Mechanical, or Biomedical Engineering with a minimum 5 years of experience in the medical device industry
Abilities / Preferred Requirements:
· Experience in a small, fast-paced startup environment
· Knowledge of manufacturing processes, fabrication methods, molding, extrusion, and manufacturing process equipment
· Understands injection molding, polymers, and commonly used materials in the medical device space.
· Experience with design and processing of medical packaging systems and sterile barriers
· Project management skills
· Problem-solving ability
· Knowledge of FDA QSR, ISO13485, ISO 14971 Risk Assessment
· Proficiency in Microsoft Office Software, Solidworks, QMS, and ERP systems.
· Demonstrated use of statistical tools, including Minitab, Sampling plans, and
Statistical Analysis
· Demonstrated experience in Equipment / Process Validations IQ/OQ/PQ and FAT/SAT
· Experience with U/D/PFMEA
· Experience with Arena document control software
· Experience in endoscopic, laparoscopic, or robotic surgical medical device development
· Experience with gastrointestinal medical device development (upper & lower GI)
· Experience with design & development of implantable medical devices
· Project management skills
· Problem-solving ability
· Excellent verbal and written communication skills
· Ability to travel up to 20% as required.
Work Conditions:
· This job may require some repetitive motions.
· This job may require lifting objects weighing up to 50lbs.
· There are no special environmental concerns (excessive heat or cold, excessively loud noises, etc.)
Job Types: Full-time, Permanent
Pay: $80,000.00 - $120,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Experience level:
Schedule:
Work setting:
- In-person
- Manufacturing facility
Application Question(s):
- Do you have a valid drivers license? Job requires travel between sites in Westwood, West Bridgewater, and Stoughton.
Ability to Commute:
- Westwood, MA 02090 (Required)
Ability to Relocate:
- Westwood, MA 02090: Relocate before starting work (Required)
Work Location: In person