Manufacturing Engineer II

Nova Biomedical Corporation; United States; On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Hybrid and flexible work arrangements

Generous PTO and paid holidays

Tuition reimbursement

Competitive 401k company match

Job summary

Nova Biomedical is seeking a Manufacturing Engineer II to support consumable manufacturing operations, including reagent sensor and tubing processes. The role resolves production issues of moderate complexity, implements process and equipment improvements, and supports product transfers with validation and change control activities.

The engineer will work cross-functionally to improve safety, quality, delivery, and process capability while maintaining compliance with quality and regulatory

Qualifications

• Bachelor's degree in Mechanical or Manufacturing Engineering or related field.
• 3 years of experience in manufacturing mechanical or related engineering.
• Experience with documentation control systems and change control.
• Familiarity with FDA quality systems and ISO 13485 preferred.

Responsibilities

• Provide day-to-day engineering support for consumable manufacturing processes and equipment.
• Lead or support structured troubleshooting and root cause investigations.
• Plan and execute engineering projects within scope, quality, cost, and timeline.
• Prepare and revise manufacturing documentation and validation protocols.
• Support IQ/OQ/PQ protocols and analyze results for deviations and reports.
• Lead continuous improvement projects using Lean and Six Sigma tools.

Skills

Interpersonal communication

Time management

Risk management

Education

Bachelors degree in Mechanical/Manufacturing Engineering

Tools

Minitab

SAP

MasterControl

SolidWorks

Job description

Job Summary

The Manufacturing Engineer II provides manufacturing engineering support for Nova Biomedicals consumable manufacturing operations including reagent sensor and tubing processes. The role independently resolves production issues of moderate complexity implements process and equipment improvements supports product and process transfers and executes validation and change control activities. The engineer works cross functionally to improve safety quality delivery process capability and manufacturing cost while maintaining compliance with applicable quality and regulatory requirements.

Responsibilities

• Provide day to day engineering support for consumable manufacturing processes equipment and products
• Investigate and resolve issues affecting safety quality throughput cost or delivery
• Provide off shift technical support and troubleshooting when needed to support manufacturing operations
• Lead or support structured troubleshooting and root cause investigations
• Define the problem analyze process and product data identify contributing causes implement corrective actions and verify their effectiveness
• Plan and execute assigned engineering projects
• Establish tasks and schedules coordinate resources monitor progress identify and communicate risks and complete deliverables within approved scope quality cost and timeline requirements
• Represent Manufacturing Engineering on assigned cross functional teams
• Provide technical input complete assigned deliverables and coordinate implementation with Manufacturing Quality R&D Supply Chain Operations and suppliers
• Prepare and revise manufacturing and engineering documentation including manufacturing variances engineering change orders validation protocols and reports SOPs work instructions and drawings in accordance with document control and quality system requirements
• Support process and equipment qualification by developing and executing approved IQ OQ and PQ protocols; analyzing results; documenting deviations; and preparing reports
• Use engineering studies DOE risk assessments and PFMEA outputs to establish and justify process requirements as appropriate
• Develop and implement tooling fixtures process aids and equipment improvements
• Define requirements; prepare design documentation; assess risks; and support testing qualification change control and transfer to manufacturing
• Support new product introduction and process transfer by developing manufacturing methods identifying equipment and tooling needs assessing process risks preparing production documentation supporting pilot builds and completing assigned transfer and validation deliverables
• Lead assigned continuous improvement projects using data analysis Lean methods Six Sigma tools and structured problem solving to improve yield scrap cycle time equipment uptime labor utilization or process capability
• Perform other duties as assigned

Experience Requirements

• Bachelors degree in Mechanical Engineering Manufacturing Engineering or a related engineering discipline is required
• 3 years of experience in manufacturing mechanical process or a related engineering field is required
• Proficiency with standard Microsoft Office applications and experience using statistical analysis enterprise resource planning and electronic document control systems
• Experience with Minitab SAP and MasterControl is preferred
• Proficiency with SolidWorks including independently developing and revising tooling fixture and component designs and associated drawings
• Experience supporting manufacturing investigations process improvements equipment changes and nonconforming product reviews
• Strong interpersonal communication time management and risk management skills
• Experience with controlled documentation investigations change control and validation practices in a regulated manufacturing environment is required
• Experience in medical device manufacturing and familiarity with FDA quality system requirements and ISO 13485 are preferred
• Six Sigma Yellow Belt certification is preferred

Physical Requirements and Working Conditions

• Ability to alternate between sitting and standing and perform activities that may include walking pushing pulling bending kneeling reaching twisting turning and climbing steps
• Ability to lift and carry up to 25 pounds periodically during a shift
• Ability to perform repetitive hand wrist and arm movements when operating equipment or using a computer
• Ability to wear required personal protective equipment which may include safety glasses safety shoes a lab coat bouffant including beard if not clean shaven gloves hearing protection a face shield or a nuisance mask

Why Work for Nova Biomedical

• Flexible Medical Dental & Vision Coverage
• Competitive 401k company match
• Bonus Program
• Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development engagement and events
• Company marketplace for lunch and snacks in our Norwood MA Billerica MA and Westbrook ME offices
• Company subsidized cafeteria in our Waltham MA office

Work Location

Waltham MA Onsite M F

Targeted Salary Range

90000 105000

Nova Biomedical believes in transparency and integrity throughout all we do including compensation The provided salary range for this role represents the expected base salary or hourly rate for this opening Actual compensation will be commensurate with the candidates experience and may vary based on individual factors such as location skills and education

About the company

At Nova Biomedical were not just building instruments were powering breakthroughs that improve lives Our smart science driven solutions are trusted in over 100 countries to speed drug development and enhance patient care Our integration brings together more than 70 years of scientific excellence with Novas cutting edge innovation forming a powerhouse of precision purpose and possibility With FDA registered ISO certified manufacturing more than 125 FDA approvals and industry trusted diagnostics were setting new standards in quality and reliability Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic IVD instrumentation dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences With headquarters in Norwood and Waltham Massachusetts and a global team of nearly 2000 employees were building a collaborative empowered culture grounded in shared values Customer Centricity Ingenuity Ownership & Accountability Collaboration and Integrity Working at Nova Biomedical means joining a mission driven organization where your contributions matter Whether youre in engineering science manufacturing or support youll be part of a team that values innovation invests in your growth and is committed to making a real world impact on global health Explore whats next with us at novabiomedicalcom

EEO Statement Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce As a part of our commitment to a diverse and inclusive workforce Nova Biomedical will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identity gender expression veteran status age mental or physical disability genetic information or any other protected class Privacy policy httpswwwnovabiomedicalcomprivacy policy