Job SummaryIn this fully onsite role, you will lead the introduction of new products and/or large capital programs for processes, equipment, and new technology upgrades.
The ideal candidate for this role will have a strong understanding of the CAPA and Change Control processes, excellent problem-solving skills, and strong communication and presentation skills. Candidate should have experience working with and getting alignment with a variety of functional support groups to accomplish improvements. We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes. Manage interns or groups of junior engineers on day-to-day tasks such as testing, reporting, drafting, and analysis work.
Essential Duties and Responsibilities- Development of scope of work, project plans, schedules, budgets, or guidelines for your projects.
- Lead project implementation from assessment through to procedure production release including equipment installation and validation activities.
- Troubleshooting manufacturing issues and problem solving for root cause associated with manufacturing processes.
- Communicates findings and proposals to upper management.
- Tracks metrics to discover areas for improvement and identify areas for improvement.
- Work with manufacturing, finance, and operations excellence to estimate production costs and project savings.
- Provides thorough instructions for successful implementation of process changes.
- Reviews production data and design specifications working in partnership with manufacturing and quality to understand critical process parameters Designs procedures for designing control charts and action plans that affect process capability and product performance.
- May incorporate inspection and test requirements into the production plan.
- Leads or provides critical review of root cause investigations and support corrective action solutions, planning and execution to ensure product quality.
- Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
- Ensures processes and procedures are in compliance with regulations, applicable safety and quality standards.
- Manages and provides sound engineering support with hands-on expertise in projects from conception through production. Interact with engineering, management, site and corporate team members and/or vendors to develop engineering specifications for new equipment or required process improvements; produce, modify, and maintain drawings; maintain project timelines; continuously evaluate projects from the tasks, resource and costs perspective, ensure delivery of the projects on time and within budget; and actively install, start-up, and validate equipment or tooling.
- Coordinate and/or perform all necessary validations and/or process engineering evaluations as needed for manufacturing equipment.
- Manage and coordinate plant and capital projects, properly document work, and maintain history of projects in appropriate project files.
- Assist in installation of new products, tooling and related processes; investigate tooling and process problems; make new product/process recommendations.
- Contributes to departmental efforts by accomplishing related tasks as needed.
- Other duties as assigned
Education- Bachelor's Degree in Engineering, or equivalent work experience required.
Work Experience- Minimum of 8 years of relevant work experience.
- Must have effective problem-solving and interpersonal skills.
- Experience authoring Validation Master Plans (VMP), Process Validation Protocols (IQ/OQ/PQ), Failure Modes and Effects Analyses (FMEA) and knowledge of Design of Experiments (DOE) and Statistical Process Control (SPC) skills.
- Experience developing User Requirement Specs (URS) for new and/or existing equipment and capable of performing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) on capital equipment.
- Capable of performing both attribute and Variable Gage R&R studies independently and developing initial process development documentation.
- Must have experience in Medical Device/Pharma or a regulated industry.
- Knowledge reading blueprints and basic understanding of Geometric Dimensioning and Tolerancing (GD&T) skills and tolerances.
- Knowledge of manufacturing processes, workflows, automation equipment and industrial techniques.
Preferred Knowledge, Skills and Abilities- Exposure to automated assembly lines and general automation principles (inputs/outputs, alarms, measurement systems, system controls)
- Experience in SolidWorks or similar 3D modeling software to support with idea generation, investigations, etc.
- Experience in MiniTab to evaluate data trends, test data, or projections of results
- Experience in medical device industry highly preferred
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company's safety policy at all times.
- Able to comply with the company's quality policy at all times
Travel Requirements10%: Up to 26 business days per year
Physical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements- The position requires frequent standing or walking, sitting for extended periods, and manual dexterity to operate equipment and handle tools or materials.
- The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.
- While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles.
- The noise level in the production manufacturing work environment is usually moderate to loud; hearing protection is required.
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