The
Manufacturing Engineer II will be a key member of the manufacturing engineering team, partnering with Management, Quality Assurance, Product Development, Supply Chain/ Logistics and Production. This role is responsible for executing manufacturing engineering activities in compliance with cGMP requirements, applicable regulatory standards, and site procedures, while ensuring deliverables are completed on time and to a high standard of quality.
Primary Responsibilities- Serve as the Manufacturing Process SME for product packaging and labeling, with ownership of production line setup, packaging configuration, labeling process, MRP setup, and manufacturing readiness to support on-time shipment of clinical products.
- Provide day-to-day production support to help ensure staff remain engaged, on task, and consistently adhere to GMP and established manufacturing procedures.
- Develop, maintain, and continuously improve manufacturing documentation, including manufacturing procedures, travelers/ device history records, BOMs, work instructions, and product specifications.
- Own and maintain the applicable process risk documentation and participate in risk analysis as needed.
- Co-own and maintain more than 50 packaging and labeling specifications and their associated manufacturing procedures, ensuring alignment with approved product configurations and labeling requirements.
- Partner closely with Supply Chain, Logistics, Quality, Regulatory, R&D, and Production to support production and clinical shipment schedules.
- Lead and support engineering changes related to packaging and labeling, including process improvement, documentation updates, product configuration changes, and implementation of corrective actions.
- Respond effectively to changing priorities and urgent field or clinical shipment needs while maintaining compliance with established manufacturing and quality system requirements.
- Understand packaging validation principles and applicable requirements to assess the impact of packaging changes, and provide appropriate engineering justification.
- Support commercial production scalability during site transfers and manufacturing expansion, including capacity planning, production line setup, equipment implementation, and equipment/process qualification.
- Design and develop manufacturing fixtures and tooling to improve process consistency, ergonomics, efficiency, and manufacturability.
- Apply 5S, standard work, and Lean and Six Sigma principles to improve workflow, reduce waste, and support scalable manufacturing operations.
- Ensure compliance with Anteris Quality System and applicable SOPs.
- Demonstrate strong attention to detail to identify procedural gaps, documentation inconsistencies and opportunities for process improvement.
- Support NCMRs, CAPAs, including root cause investigation, implementation of corrective actions, and effectiveness verification.
- Demonstrate accountability for delivering assigned work on time and provide clear, timely updates on progress, priorities, risks, and challenges to management and cross-functional stakeholders.
Skills, Knowledge, Experience & Qualifications:- BS with 2+ years of relevant experience OR MS with 1+ years of relevant experience OR an equivalent combination of education/work experience working in medical device manufacturing; Degree in Packaging Engineering preferred
- Experience in product packaging and labeling
- Preferred knowledge of statistics, quality systems and regulatory requirements.
- Well-developed collaborative approach to tasks. Ability also to work under minimal supervision.
- Technical Skills - Strong analytical and critical thinking skills, ability to troubleshoot/problem solving skills/root-cause analysis. Requires effective computer skills, experience with MS office.
- Demonstrate reliability, independence, and high output across multiple initiatives.
- Proactively manage workload and communicate progress with minimal supervision.
- Participate in MRB and team meetings, contributing expert insights and ensuring technical perspectives are heard.
- Proactive in problem solving and issue resolution.
- Communication and Comprehension Skills - Excellent interpersonal and communication skills both verbal and written with colleagues and individuals inside and outside of the company.
- Must be conscientious and proficient and have good organizational skills. Excellent attention to detail.
- Strong technical writing / reviewing skills.
- Proficient in 3D CAD (SolidWorks)
- Labeling and barcode development (GS1) using Bartender, Labelview, Easylabel or similar tools
CompensationTarget base salary range:
$90,000 - $110,000, plus eligibility for an annual short-term incentive (STI) targeted at
7% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
What We Offer:- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Collaborative and dynamic work environment with a culture of innovation and excellence.
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings:- Medical, Dental, and Vision Offerings
- Healthcare & Flexible Spending Account (HSA / FSA)
- 401k + Company Match
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Equity Program
- Paid Holidays & Vacation
- Employee Assistance Program
- Inclusive Team Environment
This is the national market pay scale.
Salary Range
$90,000-$110,000 USD
Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
