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Staff Medical Device Autoinjector Engineer

Thermo Fisher Scientific

Greenville, North Carolina • Today

Full-time

Job Details

Skills

GMP
Medical Devices
Standard Operating Procedure
Regulatory Compliance
Documentation
Product Design
Manufacturing Operations
Root Cause Analysis
Collaboration
Reporting
Training
Design Review
Quality Control
Testing
Chemical Engineering
Physics
Pharmaceutics
Quality Management
ISO 13485
Management
Assembly
Process Improvement
Lean Six Sigma
Conflict Resolution
Problem Solving
Attention To Detail
Communication
Vendor Management
Manufacturing
Innovation

GMP
Medical Devices
Standard Operating Procedure
Regulatory Compliance
Documentation
Product Design
Manufacturing Operations
Root Cause Analysis
Collaboration
Reporting
Training
Design Review
Quality Control
Testing
Chemical Engineering
Physics
Pharmaceutics
Quality Management
ISO 13485
Management
Assembly
Process Improvement
Lean Six Sigma
Conflict Resolution
Problem Solving
Attention To Detail
Communication
Vendor Management
Manufacturing
Innovation

Summary

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Summary: The Staff Medical Device Engineer will be responsible for developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates. This role involves ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors. The ideal candidate will have a strong background in pharmaceutical engineering, process improvements, and experience with Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs). We are essentially looking for a device-centric autoinjector subject matter expert.

Key Responsibilities:

Documentation and Compliance:

Ensure all documentation is accurate, up-to-date, and accessible to relevant personnel.
Compile and create documentation in accordance with relevant regulatory requirements.
Manage all post-submission Design History File (DHF) updates in collaboration with Development device teams
Support the creation and maintenance of product Design Master Records (DMRs) post-submission

Process Improvement:

Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations.
Conduct root cause analysis and implement corrective actions for process deviations.
Collaborate with cross-functional teams to optimize production processes and reduce waste.
Responble for process characterization and defining the specification(s) for the critical process parameters (CPPs) to be used for the device assembly process

FATs/SATs:

Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure equipment and systems meet specified requirements.
Coordinate with vendors and internal teams to address any issues identified during FATs/SATs.
Document and report test results, ensuring all acceptance criteria are met.

Vendor Management:

Work closely with vendors to ensure timely projects and training for equipment.
Detailed design review for the assembly and manufacture of a product

Customers:

Support product feasibility assessments.
Coordinate all transfer activities from development to operational QC for device testing
Manage qualification and validation activities associated with exhibit, submission and commercial launch batch manufacturing
Conduct feasibility assessments and determine the manufacturing strategy for device projects with the Steriles technologies

Qualifications:

Graduate level degree (Master's) in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred.
8+ years of operations experience in a pharmaceutical manufacturing environment.
Experience working with Device vendors and OEMS
Strong experience working with Autoinjectors
Knowledge of the regulatory requirements for devices and combination products with the US and EU, including the compilation of Design History Files and Design Master records.
Knowledge of Device Quality Management Systems in accordance with ISO13485 and 21CFR820
Experience of managing Device Development Projects, ideally from concept to launch
Understanding of device and drug/device combination regulatory requirements
Understanding of device design and assembly including tool development and manufacturing processes
Experience with process improvement methodologies (e.g., Lean, Six Sigma).
Excellent problem-solving skills and attention to detail.
Strong communication and interpersonal skills.
Ability to work collaboratively in a team environment.
Experience with FATs/SATs and vendor management is highly desirable.

Working Conditions:

This position may require occasional travel to vendor sites and manufacturing facilities.
Work in a fast-paced, dynamic environment with changing priorities.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10286239
Position Id: d85d70228e16ca93159a98d561ef6bf9
Posted 30+ days ago

Fitment

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Wilson, North Carolina

•

Today

Job Description Position Overview - Basic Functions & Responsibility Essential function{s) includes, but is not limited to: Reporting to the Associate Director of PTO Engineering, the Senior Specialist Engineer is responsible for providing technical support of our Manufacturing Division-Wilson packaging (including bottle/blister/oral solid dose filling and packaging lines) and medical device (autoinjector assembly and packaging/combination kit packaging) lines. Responsible for technical input

Full-time

USD 117,000.00 - 184,200.00 per year

Director, Aseptic DP Process Engineering

Wilson, North Carolina

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

Device Engineer

Zebulon, North Carolina

•

Today

Business Summary: We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as poss

Full-time

Tech Transfer/ Process Engineer III

Massachusetts

•

Today

Pay Rate Low: 80 | Pay Rate High: 100 Our client is a leading life sciences company that develops and manufactures tools and materials used in the production of biologic drugs. They are looking for a skilled Tech Transfer/Process Engineer to join their growing team in Middlesex County, MA! This is a great opportunity to contribute to an innovative life science organization! Location: Middlesex County, MA Pay rate: $80 - $100/hr. DOE Job type: 6-month contract (possibility of extension or hire)

Full-time

USD 80.00 per hour

Job Details

Skills

GMP
Medical Devices
Standard Operating Procedure
Regulatory Compliance
Documentation
Product Design
Manufacturing Operations
Root Cause Analysis
Collaboration
Reporting
Training
Design Review
Quality Control
Testing
Chemical Engineering
Physics
Pharmaceutics
Quality Management
ISO 13485
Management
Assembly
Process Improvement
Lean Six Sigma
Conflict Resolution
Problem Solving
Attention To Detail
Communication
Vendor Management
Manufacturing
Innovation

GMP
Medical Devices
Standard Operating Procedure
Regulatory Compliance
Documentation
Product Design
Manufacturing Operations
Root Cause Analysis
Collaboration
Reporting
Training
Design Review
Quality Control
Testing
Chemical Engineering
Physics
Pharmaceutics
Quality Management
ISO 13485
Management
Assembly
Process Improvement
Lean Six Sigma
Conflict Resolution
Problem Solving
Attention To Detail
Communication
Vendor Management
Manufacturing
Innovation

Summary

Ensure all documentation is accurate, up-to-date, and accessible to relevant personnel.
Compile and create documentation in accordance with relevant regulatory requirements.
Manage all post-submission Design History File (DHF) updates in collaboration with Development device teams
Support the creation and maintenance of product Design Master Records (DMRs) post-submission

Process Improvement:

Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations.
Conduct root cause analysis and implement corrective actions for process deviations.
Collaborate with cross-functional teams to optimize production processes and reduce waste.
Responble for process characterization and defining the specification(s) for the critical process parameters (CPPs) to be used for the device assembly process

FATs/SATs:

Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure equipment and systems meet specified requirements.
Coordinate with vendors and internal teams to address any issues identified during FATs/SATs.
Document and report test results, ensuring all acceptance criteria are met.

Vendor Management:

Work closely with vendors to ensure timely projects and training for equipment.
Detailed design review for the assembly and manufacture of a product

Customers:

Support product feasibility assessments.
Coordinate all transfer activities from development to operational QC for device testing
Manage qualification and validation activities associated with exhibit, submission and commercial launch batch manufacturing
Conduct feasibility assessments and determine the manufacturing strategy for device projects with the Steriles technologies

Qualifications:

Graduate level degree (Master's) in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred.
8+ years of operations experience in a pharmaceutical manufacturing environment.
Experience working with Device vendors and OEMS
Strong experience working with Autoinjectors
Knowledge of the regulatory requirements for devices and combination products with the US and EU, including the compilation of Design History Files and Design Master records.
Knowledge of Device Quality Management Systems in accordance with ISO13485 and 21CFR820
Experience of managing Device Development Projects, ideally from concept to launch
Understanding of device and drug/device combination regulatory requirements
Understanding of device design and assembly including tool development and manufacturing processes
Experience with process improvement methodologies (e.g., Lean, Six Sigma).
Excellent problem-solving skills and attention to detail.
Strong communication and interpersonal skills.
Ability to work collaboratively in a team environment.
Experience with FATs/SATs and vendor management is highly desirable.

Working Conditions:

This position may require occasional travel to vendor sites and manufacturing facilities.
Work in a fast-paced, dynamic environment with changing priorities.

Dice Id: 10286239
Position Id: d85d70228e16ca93159a98d561ef6bf9
Posted 30+ days ago

Fitment

Dice Job Match Score™

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Wilson, North Carolina

•

Today

Full-time

USD 117,000.00 - 184,200.00 per year

Director, Aseptic DP Process Engineering

Wilson, North Carolina

•

Today

Full-time

Device Engineer

Zebulon, North Carolina

•

Today

Full-time

Tech Transfer/ Process Engineer III

Massachusetts

•

Today

Full-time

USD 80.00 per hour

Staff Medical Device Autoinjector Engineer

Skills

Summary

Dice Job Match Score™

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Staff Medical Device Autoinjector Engineer

Job Details

Skills

Summary

Dice Job Match Score™

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