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SUMMARY
This position reports to the Director, Manufacturing Operations & Engineering and is responsible for manufacturing engineering at the Integra Tissue Technologies Plant located in Plainsboro NJ. This position is responsible for managing a team of engineers who provide technical support for on-going plant manufacturing operations. This position is responsible for leading projects to evaluate, analyze, and improve existing processes, implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, conduct non-conformance investigations, and execute CAPA project work which supports manufacturing operations and the Quality System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Manage a manufacturing engineering team to support process scale-up for current manufacturing operations. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly.
Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra’s procedures and statutory requirements.
Initiate, develop and implement Engineering Studies and IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Requests/Orders (ECR/ECO) and Engineering Drawings.
Oversee projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA).
Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
Project Management aimed to evaluate, analyze, and improve existing processes, support the transfer of manufacturing processes, and manufacturing process troubleshooting. Must be able to manage projects in their entirety, and also be able to perform/deliver specific project tasks as necessary. Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
Provide plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc. Provide daily analytical and technical support to meet manufacturing objectives. Provide technical input for analysis of process and equipment changes.
Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing. Evaluate and upgrade process equipment as required.
Conduct performance reviews and other HR procedures and duties for departmental staff in accordance with company policy.
Oversee and direct all performance management, training, development, job descriptions, and safety procedures for all direct reports.
MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor degree or equivalent with 5+ years of experience
Experience in the medical device, pharmaceutical or similarly regulated industry with experience in process development and/or process engineering.
Experience with Quality System Regulation, Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines is required.
Experience with biomaterials, in cleanrooms, and Lyophilization a plus.
Experience managing direct reports.
Experience with Statistical Process Control tools required (SPC, Minitab, other software).
General chemistry, processing and material expertise.
Considerable knowledge of the principles and practices of engineering as applied to various types of projects.
Ability to prepare complex technical reports, project summaries, and correspondence.
Exceptional practical problem-solving skills, excellent organizational and communication skills.
Six Sigma LEAN a plus.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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#J-18808-LjbffrAbout Dexterity
At Dexterity, we believe robots can positively transform the world.Our breakthrough technology frees people to do the creative, inspiring, problem-solving jobs that humans do best by enabling robots to handle repetitive and physically difficult work.
We’re starting with warehouse automation, where the need for smarter, more resilient supply chains impacts millions of lives and businesses around the world.Dexterity's full-stack robotics systems pick, move, pack, and collaborate with human-like skill, awareness, and learning capabilities.Our systems are software-driven and hardware-agnostic and have already picked over 15 million goods in production.And did we mention we’re customer-obsessed?Every decision, large and small, is driven by one question – how can we empower our customers with robots to do more than they thought was possible?
Dexterity is one of the fastest-growing companies in robotics, backed by world-class investors such as Kleiner Perkins, Lightspeed Venture Partners, and Obvious Ventures.We’re a diverse and multidisciplinary team with a culture built on passion, trust, and dedication.Come join Dexterity and help make intelligent robots a reality! At Dexterity, we believe robots can positively transform the world.Our breakthrough technology frees people to do the creative, inspiring, problem-solving jobs that humans do best by enabling robots to handle repetitive and physically difficult work.
About the Role
We are seeking an experienced Senior Electrical Engineer to join Dexterity’s Hardware Product team. As a Senior Electrical Engineer, you will own electrical systems architecture and design for high-performing and reliable robotics solutions. Your responsibilities will encompass various aspects of electrical systems design, integration, testing, and collaboration across multidisciplinary teams.
Accountability- Own the architecture and design of electrical systems for robotic automation products, ensuring reliability, scalability, and cost-effectiveness.
- Own components selection and their integration into the design, ensuring safe and optimal functionality.
- Design for signal integrity, minimize noise interference and establish effective grounding practices to maintain system performance and reliability.
- Utilize advanced eCAD tools to meticulously create and review electrical schematics, ensuring alignment with product requirements, mechanical considerations, and adherence to electrical safety standards.
- Create wiring configurations and harness designs for reliable electrical performance, ease of assembly, and serviceability.
- Write and maintain design documentation that clearly communicates design considerations and trade-offs.
- Support the initial product installations at customer facilities, including troubleshooting and training.
- Collaborate with the Mechanical engineering counterparts to ensure seamless integration of electrical modules/PCBAs and harnesses into the product CAD designs.
- Collaborate with Hardware Test engineers to develop and execute robust testing plans to verify the functionality and performance of electrical systems, analyzing test results to drive continuous improvement.
- Collaborate with Manufacturing engineers(internal/external) to ensure accuracy in BOM, define and oversee assembly and testing processes, and troubleshoot any electrical system issues to unblock manufacturing.
- Engage in cross-functional collaboration with Mechatronics engineers to facilitate the development and integration of drivers essential for operation and communication within the robotics solutions.
- Work with design partners or ODMs to jointly develop next-generation HW components to optimize the performance and cost of our products.
- BS or higher in Electrical Engineering, related discipline, or equivalent experience.
- 10 or more years of related work experience including a track record of taking a product from conception to volume manufacturing.
- Experience with motors, servo drivers, sensors, communication protocols (EtherCAT, CANBUS, etc.), robot arms, and controllers.
- Experience with lab test instruments such as multimeters, oscilloscopes, DC loads, power supplies, spectrum analyzers, etc.
- Experience with circuit design including analog circuits, digital logic, high-speed signals, filtering, high-voltage circuits, etc.
- Experience using eCAD tools for designing electrical systems and schematics.
- Experience with hardware product certification processes, best design practices for compliance, and standards (FCC, NFPA 79, UL, CE, IEC).
- Experience in troubleshooting control systems, PCBAs, and electrical system issues.
- Familiar with Hardware Product Life Cycle stages and product lifecycle management tools and processes from concept to volume manufacturing.
- Familiar with using a PLM system (Arena, Agile, Teamcenter) for the development life cycle on a day-to-day basis.
- Experience working with engineering off-shore subcontractors, vendors, and global contract manufacturers.
- Experience with power electronics design (motor drive, SMPS, inverters) and practical experience in battery-powered systems design - an advantage
- Experience with electronics for industrial automation such as PLCs, functional safety modules, and safety sensors - an advantage.
- Strong technical writing skills and ability to communicate technical information to technical and non-technical functions.
- Able to work on multiple projects and global engineering teams concurrently with great attention to detail.
- Fast learner, can autonomously translate learning into execution.
$135,000 - $175,000 a year
Base pay is one element of our Total Rewards package which may also include comprehensive benefits and equity etc., depending on eligibility. The annual base salary range for this position is from $135,000 to $172,000. The actual base pay offered will be determined on factors such as years of relevant experience, skills, education etc. Decisions will be determined on a case-by-case basis.
Equal Opportunity Employer - We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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