Manufacturing Engineer 2

Company Summary

EmeraNova and its affiliates companies (“the Company”) is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact.

Position Summary

The Manufacturing Engineer II is the engineering point of contact for the production floor. This role keeps production running. This role focuses on resolving equipment and process issues, improving yield and throughput, and supporting line extensions and product changes from development through routine production.

This is a hands-on, floor-facing role. The Manufacturing Engineer II spends significant time in the manufacturing and cleanroom areas working directly with operators, supervisors, and technicians. They own defined processes and equipment end to end, lead their own improvement projects, and partner with Quality, R&D, Facilities, and Supply Chain to keep production capable and compliant.

Essential Functions

Manufacturing and Production Support

• Serve as the primary engineering resource for assigned production lines and processes, responding to floor issues that stop or slow production and driving them to resolution.
• Troubleshoot process excursions, yield loss, and quality escapes using structured problem solving; identify root cause and implement corrective action.
• Partner daily with production supervisors and operators to remove barriers, clarify work instructions, and confirm that engineering solutions hold once implemented.
• Own and maintain manufacturing documentation for assigned processes, including procedures and work instruction, work orders, BOMs, travelers, and process parameters.
• Maintain accurate ERP data for assigned products.
• Establish and track process performance metrics such as yield, scrap, rework, cycle time, and downtime. Identify trends and suggest improvements based on data.
• Support production planning with capacity analysis, labor standards, cost/benefit analysis, COGS calculations and line balancing for assigned areas.

Equipment and Tooling

• Own assigned production equipment, tooling, and fixtures from specification through sourcing, installation, qualification, and ongoing performance.
• Lead resolution of equipment issues, including diagnosis, troubleshooting, spare parts strategy, and permanent corrective action for recurring failures.
• Specify, source, and justify new or replacement equipment and tooling, including user requirements definition, vendor evaluation, and factory and site acceptance testing.
• Design or specify fixtures, tooling, and workstation layouts that improve ergonomics, repeatability, and throughput.
• Define engineering maintenance requirements for owned equipment and partner with Facilities on execution, including calibration schedules and critical spares.
• Track equipment reliability and downtime data and use it to prioritize improvement and replacement decisions.

Continuous Improvement

• Identify, scope, and lead improvement projects that reduce cost, scrap, cycle time, and variation in assigned areas.
• Apply Lean and Six Sigma methods (value stream mapping, standard work, 5S, kaizen events, SMED, mistake proofing, design of experiments, and statistical process control) to production problems.
• Build the business case for improvement work, including cost and benefit estimates, and report results against baseline after implementation.
• Participate in and help facilitate structured improvement events alongside the broader Operational Excellence effort.
• Mentor operators, technicians, operations supervisors and junior engineers in basic problem solving and improvement tools.

Line Extensions and Product Changes

• Serve as the manufacturing representative for line extensions, new sizes and configurations, packaging changes, and component or supplier changes to existing products.
• Assess manufacturability, capacity, tooling, and labor impact of proposed changes and communicate them before commitments are made.
• Support design transfer from R&D into production, including process development, pilot and scale-up builds, first article inspection, and production readiness.
• Develop and qualify packaging and labeling configurations, including testing to applicable ISO and ASTM standards.
• Build and validate the manufacturing documentation set required to release a new configuration to production.
• Support new product introduction activity as the business builds out its NPI capability.

Validation and Qualification

• Author and execute process, equipment, and software validation protocols and reports, including IQ, OQ, and PQ.
• Develop sampling plans and statistical rationale appropriate to the risk of the process.
• Support test method validation and gage repeatability and reproducibility studies for inspection and in-process checks.
• Maintain the validated state of assigned processes and equipment, including periodic review and requalification after change.

Documentation, Change Control, and Quality Support

• Initiate and own engineering change orders through the change control process, including impact assessment, documentation updates, and effectivity.
• Investigate nonconformances and deviations in assigned areas, determine root cause, and implement corrective and preventive action.
• Support CAPA, complaint investigation, and risk management activities, including process FMEAs and control plans.
• Support internal and external audits and inspections by explaining assigned processes and producing supporting records.
• Develop training content for process and equipment changes and support operator qualification.

Preventive Maintenance

• Define preventive maintenance requirements and acceptance criteria for engineering-owned production equipment.
• Partner with Facilities, who owns execution and scheduling of the preventive maintenance program, on work orders that require engineering input or technical judgment.
• Review maintenance history for assigned equipment and convert recurring findings into permanent engineering fixes.

Compliance and Safety

• Follow and enforce Good Manufacturing Practices, Good Documentation Practices, Standard Operating Procedures, and Work Instructions in all areas of responsibility.
• Work within a cleanroom environment and follow gowning, environmental monitoring, and contamination control requirements.
• Build safety and ergonomics into process, equipment, and layout decisions, and support environmental, health, and safety reviews for new equipment and materials.

This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.

Minimum Qualifications

Education

• Bachelor's degree in Mechanical, Industrial, Biomedical, Manufacturing, or Chemical Engineering, or a related technical field.

Experience

• 2-4 years of manufacturing engineering experience within a regulated industry.
• Demonstrated ownership of production equipment and processes, including ability to troubleshoot and problem solve equipment issues.
• Experience authoring and executing validation protocols and working within a formal change control system.

Certifications

• Lean Six Sigma experience preferred.

Preferred Qualifications

• Experience in a cleanroom or aseptic manufacturing environment.
• Experience with tissue, biologics, or combination products.
• Experience supporting product launches or line extensions from development into routine production.
• CAD proficiency for fixtures, layouts, and component drawings.
• Experience with ERP implementation or data ownership.

Knowledge, Skills, and Abilities

• Working knowledge of 21 CFR 820, 21 CFR 1271, and ISO 13485.
• Structured problem solving and root cause analysis.
• Applied statistics for manufacturing, including capability studies, sampling plans, statistical process control, and basic design of experiments.
• Understanding of routings, BOMS, work orders, and other ERP elements required to run a compliant manufacturing operation.
• Clear technical writing, including protocols, reports, investigations, and work instructions.
• Ability to work effectively with operators and supervisors on the floor and with cross-functional partners in Quality, R&D, Facilities, and Supply Chain.
• Ability to manage several concurrent priorities and keep committed dates in a fast-moving environment.
• Proficiency with Microsoft Office, and familiarity with electronic quality management and maintenance management systems.

Physical Requirements

• Ability to stand and walk for extended periods on the manufacturing and laboratory floor; this role may spend a portion of the day in production areas.
• Prolonged periods of sitting at a desk and working on a computer.
• Ability to wear required personal protective equipment (PPE) and follow cleanroom gowning procedures.
• Ability to occasionally lift and/or move up to 25 pounds.
• Ability to communicate effectively in person, by phone, and via video conference.

Work Environment

Employees in this role may be exposed to a variety of environmental, activity-related, and ergonomic hazards throughout the workday. Environmental risks include potential spills, inadequate ventilation, exposure to extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, and fall hazards. Activity-related hazards may involve working around burn or heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks. Ergonomic hazards are also present, including lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing. Employees must remain aware of these hazards to reduce the risk of injury in the workplace.

Travel Requirements

Minimal. Occasional travel to supplier or contract manufacturer sites may be required, estimated at less than 5 percent.

What We Offer

Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.

• Competitive salaries
• Health, dental, and vision insurance
• Retirement plans
• Tuition reimbursement
• Generous paid time off
• Employee assistance program

Employment Statement

The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law.

In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources.

Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law.

The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable.

Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.

I acknowledge that I have received and reviewed this job description. I understand the general duties and expectations of my position. I understand this job description does not create a contract of employment and that my duties may change at the discretion of the Company.