Lead Manufacturing Process Engineer

2 weeks ago

Mason, United States AtriCure Full time

AtriCure, Inc. is at the forefront of providing groundbreaking solutions for the management of Afib and associated conditions, impacting over 33 million individuals globally. Our innovative technologies are utilized by electrophysiologists and cardiothoracic surgeons worldwide to effectively treat Afib and mitigate related complications. Our Isolator Synergy Ablation System was the first medical device to gain FDA approval for persistent Afib treatment, while our AtriClip Left Atrial Appendage Exclusion System products are recognized as the leading LAA management devices globally. Additionally, our Hybrid AF Therapy offers a minimally invasive approach for long-standing persistent Afib patients, and our cryoICE cryoSPHERE probe is designed for temporary ablation of peripheral nerves, delivering pain relief during cardiac and thoracic procedures. For further details, please visit our website.

We cultivate an inclusive environment that values diverse experiences and individuals, ensuring that everyone feels welcomed and valued. Our supportive programs and resources are designed to provide equitable opportunities for personal and professional growth.

POSITION OVERVIEW:

The Senior Manufacturing Engineer will play a pivotal role in the design, qualification, verification, and validation of manufacturing processes. This position demands creativity and collaboration to help achieve the company’s objectives of delivering market-leading products that enhance patient outcomes.

KEY RESPONSIBILITIES:

  • Collaborate on projects involving both internal and external design and manufacturing resources, focusing on:
    • Evaluating component designs to identify opportunities for Design for Manufacturing. Assess critical component functions and determine optimal manufacturing techniques.
    • Analyzing proposed component tolerances and contributing to manufacturing capability assessments, with a strong understanding of GD&T.
    • Reviewing device assembly requirements to identify Design for Assembly opportunities, including various joining techniques.
    • Providing input on systems test requirements for ongoing production.
    • Defining high-level manufacturing systems and workflows.
    • Selecting suppliers for parts and equipment.
    • Coordinating the fabrication of parts and equipment.

MANUFACTURING PROCESS EXPERTISE:

  • Possess knowledge of general manufacturing technologies, particularly low to medium volume processes.
  • Engage with external suppliers to define, document, analyze, and qualify their manufacturing processes.
  • Identify and implement new vendors, processes, materials, and technologies to enhance product quality and reduce costs.
  • Lead the development and validation of manufacturing processes for new products, ensuring simplicity, cost-effectiveness, and reliability.
  • Recognize and execute cost reduction opportunities related to manufacturing and products.
  • Familiarity with efficiency strategies such as Lean, Six Sigma, and Value Stream Mapping.

TOOLING AND EQUIPMENT:

  • Define and communicate fixture concepts, integrating production capabilities.
  • Understand ergonomics related to repetitive stress injuries.
  • Collaborate with designers and engineers on manufacturing-related equipment and fixture development.
  • Track project schedules and costs for tooling and equipment.
  • Ensure proper installation of new equipment and establish preventive maintenance and calibration plans.

VERIFICATION AND VALIDATION:

  • Develop detailed process qualification strategies, defining statistical sample sizes based on industry standards.
  • Create Process FMEAs to inform robust manufacturing processes and determine inspection requirements.
  • Write and execute process qualification protocols and reports, adhering to quality system standards.

MANUFACTURING LOGISTICS:

  • Understand supply chains, lead times, and raw material availability.
  • Make informed make vs. buy decisions on parts and processes.
  • Construct Bills of Material with appropriate units of measure and inventory points.
  • Utilize MRP and other planning systems effectively.
  • Create manufacturing routers and understand labor collection and work centers.
  • Analyze standard costing and variances through time studies.

DOCUMENTATION:

  • Document all work in compliance with quality system requirements.
  • Release process documentation using tools such as Visio, Excel, and Word.
  • Write clear and detailed process instructions and test protocols.
  • Develop process maps and FMEAs for all processes.
  • Document intellectual property appropriately.

COMMUNICATION:

  • Effectively communicate manufacturing and process issues to cross-functional teams and suppliers.
  • Demonstrate proficiency in computer communication tools and design documentation.

LEADERSHIP AND PLANNING:

  • Plan and track tasks to align with project objectives.
  • Share best practices among manufacturing engineers.
  • Guide junior engineers and technicians in their efforts.

ADDITIONAL REQUIREMENTS:

  • Consistent and predictable attendance.
  • Ability to thrive in a fast-paced environment.
  • Strong decision-making and judgment skills.
  • Ability to prioritize tasks and multitask effectively.
  • Collaborative mindset and ability to work well with others.

BASIC QUALIFICATIONS:

  • Bachelor's degree or equivalent combination of education and experience.
  • 7+ years of relevant experience.
  • Ability to lead manufacturing engineering efforts with minimal guidance.
  • Proficiency in selecting and qualifying manufacturing processes.
  • Experience in reviewing product designs for tolerances.
  • Expertise in coordinating equipment and fixture development.
  • Experience in developing and executing process qualification strategies.
  • Understanding of manufacturing documentation and logistics.
  • Strong cross-functional communication skills.
  • Experience in inspection/testing and data analysis.
  • Proficient in computer/data entry and report writing.
  • Problem-solving and troubleshooting skills.
  • Ability to read technical specifications and blueprints.
  • Willingness to travel as needed.

PREFERRED QUALIFICATIONS:

  • Graduate degree.
  • Experience in assembly and machining.
  • Background in computer networking and supervision.
  • Familiarity with regulatory processes and statistical applications.
  • Financial analysis experience.

OTHER REQUIREMENTS:

  • Ability to walk, sit, or stand as required.
  • Occasional bending and lifting may be necessary.
  • Ability to lift up to 10 pounds regularly.
  • Successful completion of pre-employment drug screening and background check is required.

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