Manufacturing Engineer II

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About Instylla:

Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The company's flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.

Position Summary/Role and Responsibilities:

The Manufacturing Engineering role is central to maintaining and improving the manufacturability, reliability, and compliance of Instylla's embolic product lines and associated delivery devices. The Manufacturing Engineer - Sustaining will lead sustaining engineering activities with a primary emphasis on process changes (both internal and at suppliers), raw material and component substitutions, and supplier qualification efforts. The successful candidate will work cross-functionally with Production, Quality, R&D, Regulatory Affairs, and Supply Chain to ensure all changes are properly evaluated, controlled, and documented within Instylla's Quality Management System. The Manufacturing Engineer will also be involved in the qualification of equipment and the validation of processes.

Essential Duties & Accountabilities:

Vendor & Supplier Change Management

• Serve as the primary engineering point-person for supplier-initiated changes.
• Evaluate supplier change notifications (SCNs) considering technical impact and lead required design or process verification efforts.
• Support supplier qualification activities, including first article inspections (FAIs), process audits, and supplier visits.
• Assimilate required supplier technical documentation in Instylla QMS.
• Collaborate with Supply Chain and Quality to assess alternate suppliers.

Sustaining Engineering & Process Improvement

• Own and execute sustaining engineering projects from initiation through closure, including the change assessment process.
• Investigate and resolve production nonconformances, field complaints, and CAPAs related to manufacturing processes or component performance.
• Identify and implement process improvements targeting yield, throughput, cycle time, and cost reduction while maintaining a commitment to quality and patient safety.
• Develop and revise process specifications, work instructions (WIs), assembly procedures, and manufacturing aids in accordance with DHF and DMR requirements.
• Perform and document process validations (IQ/OQ/PQ) and design verification activities as required by change scope.
• Execute responsibilities in accordance to Good Manufacturing Practices and Good Documentation Practices.
• Support and/or execute equipment calibration and preventative maintenance activities.

Qualifications and Education Requirements:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, or a related discipline.
• 2+ years of experience in the design, development or sustaining engineering activities related to medical devices, or similar.
• Experience with developing manufacturing methods and processes including tooling/fixtures.
• Working knowledge of Good Manufacturing Practices and Good Documentation Practices.
• Ability to understand specifications, technical documents, and procedures with demonstrated ability to ensure products meet specifications.
• Good written and verbal communication skills with ability to speak effectively with peers, auditors, service suppliers and management.
• Hands-on experience with process validation methodologies (IQ/OQ/PQ) and statistical analysis (DOE, capability studies, Gage R&R).

Preferred Skills:

• Excellent hand/eye coordination and specific vision abilities required including color vision, close vision and ability to see fine details under magnification.
• Experience with peripheral embolic devices, catheter-based therapies, or other vascular/interventional products.
• Familiarity with embolic materials including liquid embolics, microspheres, coils, or similar technologies.
• Knowledge of polymeric materials, adhesives, and/or biocompatible coatings relevant to vascular device manufacturing.
• Experience with Class II or Class III medical device manufacturing under 21 CFR Part 820 and/or EU MDR.
• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification is a plus.
• Experience with electronic ERP systems such as QAD, Oracle, SAP or similar.
• Experience with chemical processing, such as pharma manufacturing or similar.
• Inspection techniques using measurement instruments such as gauges, calipers, comparators, and microscopes.
• Ability to operate semi-automated and manual equipment.
• Attention to detail needed to execute production procedures, perform product inspections, accurately complete documented records and ensure compliance to SOPs and other documented practices.
• Must be able to multi-task, meet established deadlines and work with supervisor to prioritize changing demands.
• Working knowledge of business software systems (e.g., MS Office, Excel, email, etc.)
• Ability to work independently or with teams.
• Takes responsibility for assignments. Must be self-motivated and possess good organizational skills.
• Experience with 3D CAD software (SolidWorks or similar).

Working Conditions:

• Ability to work in cleanroom garments
• Ability to work in standing and/or seated positions
• Ability to lift up to 20 pounds
• Ability to work in office, chemical laboratories and assembly environments