Senior Engineer, ManufacturingEnable Injections Inc • Cincinnati, OH, United States
Senior Engineer, Manufacturing
Enable Injections Inc • Cincinnati, OH, United States
2 days ago
Job type
- Full-time
Job descriptionExperience with medical device manufacturing (heat staking, ultrasonic welding, press assembly, adhesives, leak testing) and inspection technologies (vision systems. Pressure decay, flow testing) Experience programming vision systems, robotics, and PLC Experience designing and implementing high-volume manufacturing equipment preferred, i.e., production 1M+ annual, cycle time Six Sigma Yellow / Green Belt Certification Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings (Solidworks preferred) Ability to create experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred) Strong technical writing skills (planning, protocol writing, execution, report writing, Operating Procedures) Knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley preferred) Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ) Must be able to work effectively on electrical, mechanical, and / or software related issues associated with equipment Strong analytical and creative problem-solving skills, able to provide solutions to complex technical challenges Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook) Communicate effectively through both verbal presentation and technical writing to various internal stakeholders of varying technical abilities Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives. Demonstrated technical coaching and leadership of peers Strong demonstrated ability to deliver manufacturing projects in a timely manner Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities Solid ability to understand complexity and navigate ambiguity to influence at the department level Plan and carry out multiple projects concurrently Ability to analyze problems and troubleshoot solutions Apply strong cognitive ability to collecting, processing, and disseminating information Understand current state and dynamics of the business Ability to foster teamwork, collaboration, negotiation, and influencing others Consistently open and approachable Engage colleagues and partners with the Enable Values in mind Ability to maintain a positive attitude, show empathy for others, and always do the right thing Ability to understand your own emotions and their effects on your performance Ability to express your emotions appropriately and have a positive impact on others in support of company goals and a healthy work environment Excellent time management skills Must be able to remain in a stationary position for extended periods of time Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time Position requires being physically present on the premises during regular company hours or as approved by management Manufacturing equipment specification, design, development, construction, implementation, or modification Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and / or the modification of part / mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes Assist in Equipment Qualification (installation, operational and process qualifications (IQ / OQ / PQ)) to meet regulatory requirements Standard Operating Procedures creation, revision and implementation including necessary change order, training and qualification activities Apply engineering principles and methods to understand and provide solutions to complex technical challenges Identify and coordinate activities with outside suppliers and consultants as required. Interface with and select suitable vendors for the procurement of equipment Provide DFM and DFA guidance for development of robust product design in collaboration with Product Development Develop test methods and fixtures to prove functionality of sub-assemblies and final product. Select appropriate test methods and analyze test data to challenge the effectiveness of assembly equipment and processes Prepare overall project proposals including cost estimates and schedule for designated projects. Assign priority and schedule tasks to provide timely solutions to achieve results Resolve internal and external (customer or supplier) issues related to manufacturability and performance of product Maintain and repair equipment Delegate tasks to technicians and co-ops within the department Participate in cross functional teams and ideation sessions Work with functional managers and partners to ensure project goals are met Provide technical guidance and coaching of other engineers Contributes to project planning and execution to meet schedule and budget requirements Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms
Location : Onsite
Status Type : Full Time
QUALIFICATIONS
Required :
- Bachelor's Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university; or education / experience equivalent
- A minimum of 6 years of manufacturing engineering (equipment / process design and support) in a regulated industry such as Medical Device, Pharmaceutical, or food; OR a master's degree in related field plus 4 years' experience
Preferred :
Skills & Competencies :
Physical Requirements :
RESPONSIBILITIES :
Create a job alert for this search
Senior Manufacturing Engineer • Cincinnati, OH, United States
Related jobs
At ITT, we have a clear purpose as an organization - to provide our customers with cutting-edge solutions to help solve their most critical needs across key global end markets.Our continuous improv...Show more
Solve Industrial Motion Group strives to be the trusted source for engineered bearings and power transmission solutions.Supported by a diverse range of products within Solve’s brand portfolio...Show more
At ITT, we have a clear purpose as an organization - to provide our customers with cutting-edge solutions to help solve their most critical needs across key global end markets.Our continuous improv...Show more Senior Process Engineer, Manufacturing at Enable Injections, Inc.Bachelors Degree in a technical discipline (e.Engineering or Science) and / or equivalent education / experience.Minimum of 6 years of e...Show more 
Industry : Aerospace / Defense / Advanced Materials | Full-Time On-Site.Metcut provides specimen manufacturing, mechanical, thermal, and structural testing expertise to clients across commercial and...Show more
Design and develop processes and methods for major engineering projects to ensure that products and services provided meet all contractual, program, design and quality requirements.Analyze, organiz...Show more
Manufacturing Engineer A&P Technology is a seventh generation, family-owned, world leading-producer of precision braided textiles.
Our leadership in braiding technology is a direct result of our ong...Show more
Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow.
Your work will contribute to the production of advanced jet engines, com...Show more GE Aerospace is a world-leading provider of jet engines, components, and integrated systems for commercial and military aircraft.
At GE Aerospace, we are dedicated to pushing the boundaries of aviat...Show more GE Aerospace is a world-leading provider of jet and turboprop engines, components, integrated digital, avionics, electrical power and mechanical systems for commercial, military, business and gener...Show more 
Be involved in the product life cycle of for the defense and aerospace industry! We are in search of manufacturing engineers to join our team of experts! If this is THE job for you, just complete t...Show more
L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do.Our employees are unified in a shared dedication to our customers' mission and quest ...Show more
Develops, evaluates, and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly m...Show more GE Aerospace Edison Works Advanced Programs has several job openings for manufacturing engineers.We are looking great talent from high experienced to early career who have a passion of manufacturin...Show more The aerospace industry demands advanced manufacturing processes to produce high-performance components that meet stringent safety, quality, and reliability standards.
Brazing and joining of aerospac...Show more The Senior Manufacturing Engineer role will provide non-conventional machining process capability and development associated with Edison Works Advanced Programs.
The primary responsibility of this r...Show more 
L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do.Our employees are unified in a shared dedication to our customers' mission and quest ...Show more
Bilstein of America supplies products to a wide range of Original Equipment Automotive Manufacturers as well as Aftermarket and Motorsports customers.
Our Aftermarket operations are based out of Pow...Show more
Manufacturing Engineer
ITT Cannon LLC • Hebron, KY, US
Permanent
Last updated: 7 days ago • Promoted
Manufacturing Engineer
Solve IMG • Loveland, OH, US
Full-time
Last updated: 30+ days ago • Promoted
Manufacturing Engineer
ITT Cannon • Hebron, KY, United States
Permanent
Last updated: 2 days ago • Promoted
Senior Process Engineer, Manufacturing
Enable Injections Inc • Cincinnati, OH, United States
Full-time
Last updated: 2 days ago • Promoted
Senior Engineer - Composite Materials
METCUT RESEARCH ASSOC • Cincinnati, OH, US
Full-time
Last updated: 30+ days ago • Promoted
Engineer, Manufact I
Barnes Group • West Chester, OH, United States
Permanent
Last updated: 2 days ago • Promoted
Manufacturing Engineer
A&P Technology, Inc. • Cincinnati, OH, US
Full-time
Last updated: 3 days ago • Promoted
Senior Producibility & Manufacturing Engineer
GE Aerospace • Evendale, OH, United States
Permanent
Last updated: 2 days ago • Promoted
Lead Manufacturing Engineer
GE Aerospace • Sharonville, OH, United States
Permanent
Last updated: 2 days ago • Promoted
Lead Additive Manufacturing Engineer
GE Aerospace • West Chester, OH, United States
Permanent
Last updated: 30+ days ago • Promoted
Manufacturing Engineer
General Tool Co • Cincinnati, OH, US
Full-time
Last updated: 3 days ago • Promoted
Specialist, Manufacturing Engineer (FOS)
L3Harris • St Bernard, OH, United States
Full-time
Last updated: 2 days ago • Promoted
Manufacturing Engineer
UIC • Sharonville, OH, United States
Full-time
Last updated: 2 days ago • Promoted
Senior Manufacturing Engineer
GE Aerospace • Evendale, OH, United States
Permanent
Last updated: 30+ days ago • Promoted
Senior Manufacturing Engineer - Brazing and Joining of Aerospace Alloys
GE Aerospace • Sharonville, OH, United States
Permanent
Last updated: 2 days ago • Promoted
Senior Manufacturing Engineer, Non-Conventional Machining
GE Aerospace • Sharonville, OH, United States
Permanent
Last updated: 2 days ago • Promoted
Specialist, Manufacturing Engineer (FOS)
L3 Technologies • Cincinnati, OH, United States
Full-time
Last updated: 30+ days ago • Promoted
Manufacturing Engineer
thyssenkrupp Bilstein of America, Inc. • Hamilton, OH, United States
Full-time
Last updated: 13 days ago • Promoted