Description
About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary:
The Sr. Project Engineer is primarily responsible for leading a cross functional project team that includes Quality, Engineering and Production. This position oversees the development, documentation and validation of new and modified customer products by maintaining established timelines, communication of project status internally and to customers. They also manage transferring projects to Production with a cradle to grave philosophy for programs. The Sr. Project Engineer must meet agreed upon delivery dates and established product requirements while ensuring the greatest level of manufacturability for products transferred to Production. This position will work closely with members of the Quality Assurance, Manufacturing, Tooling, Materials Science and Process Engineering teams to deliver projects to help achieve organizational goals. They will also work individually and on teams to execute organizational projects for continuous improvement in various manufacturing processes.
Key Responsibilities:
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Lead and manage the entire (NPI) New Product Introduction process from concept to commercialization ensuring effective collaboration among all stakeholders.
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Collaborate closely with product development teams to provide input on design for manufacturability cost-effective production processes and efficient assembly methods.
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Interface with customers regarding part requirements and mold designs and may serve as a primary contact on projects of moderate complexity.
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Develop and maintain detailed project plans including timelines, milestones and critical path activities. Track and report progress against established goals.
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Coordinate cross-functional teams including engineering manufacturing, materials science, procurement and quality assurance to ensure alignment and timely execution of NPI activities.
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Conduct feasibility studies and risk assessments to identify potential challenges and propose appropriate mitigation strategies.
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Collaborate with suppliers and vendors to ensure timely availability of materials tooling and equipment necessary for NPI projects.
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Design and execute validation and verification plans including process qualifications equipment validations and product testing to ensure compliance with quality standards and customer requirements.
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Develop and execute process validations (IQ, OQ & PQ). Generate validation completion reports with cross-functional team including quality and metrology department. Final reports to include:
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Develop validation protocol activities
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Dimensional reports and analysis
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Engineering studies, DOE
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FMEA, Control Plan, Process Flow
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Confirmation of all validation activities executed including written procedures
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Drive continuous improvement initiatives to optimize procedures, reduce costs and enhance product quality and manufacturability.
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Maintain accurate documentation including engineering change orders, bill of materials and work instructions to support NPI activities.
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Provide regular project updates to stakeholders including management highlighting progress risks and proposed solutions.
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Utilize 3D modeling software to examine and form a better understanding of customer supplied models for quoting and/or tooling builds.
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Create quotations on estimated costs for tooling, automation and machinery required for a successful product launch.
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Oversee prototype and material development projects.
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Involvement in design and development of new projects.
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Prototyping
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Part and tool design verification
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Provide engineering support to manufacturing on existing product lines as necessary.
Must Have:
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A Bachelors degree in a STEM related field
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5+ years of experience as a Project Engineer or in a similar role within a manufacturing environment.
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Familiarity with project management methodologies and tools with a track record of successfully managing complex projects.
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Familiarity with validation (IQ OQ PQ PQP etc.) of equipment and tooling.
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Proficiency in dimensioning and Geometric Dimensions and Tolerancing (GD&T) principles is required.
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Understanding of quality management systems and experience in implementing quality assurance processes.
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Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced manufacturing environment.
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Strong computer skills including the MS Office suite, MS Project, AutoCAD and SolidWorks.
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Must be able to fully interpret technical drawings, specifications, illustrations and written documents.
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Must be able to read write and speak fluent English.
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Must demonstrate good organizational skills.
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Strong analytical skills.
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Willingness to travel if required.
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Experience in molding methods is a plus.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
