Atrium Medical

Sr. Industrial Engineer, R&D - Wayne, NJ

Atrium Medical • $120K — $135K *
Wayne, NJ 07470In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • Master's or Bachelor's degree in engineering or related field with 6+ years of experience
  • Six Sigma Black Belt or Green Belt certification preferred
  • Expertise in Design for Manufacturability (DFM) principles
  • Hands-on experience in process validation (IQ/OQ/PQ) and statistical analysis
  • Proficiency in CAD tools (SolidWorks, Creo) and GD&T methods
  • Experience with automated assembly systems or robotics
  • Knowledge of regulatory audit processes and requirements.

Responsibilities

  • Establish and standardize DFM and DFSS best practices across engineering teams
  • Lead design phases influencing product architecture and material selection
  • Drive Design for Six Sigma methodologies to meet critical-to-quality requirements
  • Develop and optimize manufacturing processes including molding and automated assembly
  • Lead large scale process validations and establish long-term capability targets
  • Serve as technical escalation point for complex manufacturing challenges
  • Collaborate with Operations and Quality to enhance throughput and reduce scrap.

Benefits

  • Comprehensive medical, dental, and vision insurance
  • 401(k) plan with company match
  • Generous paid time off and holidays
  • Opportunities for professional development and training
  • Flexible work arrangements available.
Full Job Description
Job Overview
  • This position provides technical leadership in the development, optimization and sustaining of manufacturing processes for medical devices in accordance with Getinge's Quality system and regulatory requirements (ISO 13485 and FDA 21 CRF Part 820).
  • This individual is a key resource during Design for Manufacturability (DFM), collaborating closely with cross-functional teams to ensure current and new products are scalable, robust, cost-effective, and production-ready.
  • Leadership cross-functional initiatives, drive strategic improvements, oversee process validations, implement continuous improvement strategies, and support commercial-scale operations.


Job Responsibilities and Essential Duties

Design for Manufacturability (DFM), Design For Six Sigma (DFSS) & Product Development
  • Establish and standardize DFM and DFSS best practices, templates, and guidelines across engineering teams.
  • Lead early design phases to influence product architecture, material selection to ensure scalability, robust manufacturability, and cost-optimized solutions
  • Drive Design for Six Sigma methodologies (DMADV/IDOV) during product development to ensure critical-to-quality (CTQ) requirements are met.
  • Integrate Design for Cost (DFC) principles into product and process development, ensuring cost-effective material choices, processes, and tooling strategies.
  • Provide technical leadership in DFM reviews, tolerance analyses, design risk assessments, and capability studies.
  • Translate product requirements into manufacturing specifications, tooling designs, and process control strategies.
  • Support prototype builds and pilot manufacturing, documenting design/assembly issues and implementing corrective actions.

Process Development & Validation
  • Develop and optimize manufacturing processes including molding, machining, laser processing, automated assembly, packaging, and/or sterilization workflows.
  • Lead large scale process validations (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations.
  • Establish long-term process capability targets, implement control strategies, and ensure audit readiness.
  • Apply DFSS tools such as DOE, and tolerance stack-ups to guide process optimization.

Manufacturing Support & Continuous Improvement
  • Serve as the technical escalation point for complex manufacturing challenges, driving root-cause investigations and high-impact CAPAs to closure.
  • Lead yield improvement initiatives, cost-reduction programs, and process harmonization across multiple product families.
  • Partner with Operations and Quality to enhance throughput, reduce scrap, optimize workflow, and expand manufacturing capacity.
  • Lead Lean/Six Sigma initiatives targeting waste reduction, workflow optimization, and standardization.

Cross-Functional Collaboration
  • Act as the primary technical interface in a cross-functional team as a Core Team member
  • Lead technical discussions with suppliers on component manufacturability, material selection, tooling design, and qualification of new technologies.
  • Apply Design for Cost and Lean principles to reduce waste, optimize workflow, and lower overall cost of goods.
  • Partner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity.

Minimum Requirements
  • Master's (Preferred) or Bachelor's degree in Industrial, Mechanical, Manufacturing Systems, Biomedical Engineering, Biomedical Engineering, or related technical field with 6+ years of experience.
  • Certification in Six Sigma Black Belt (Preferred) or Green Belt

Required Knowledge, Skills and Abilities
  • Demonstrated expertise in Design for Manufacturability (DFM) principles and tools.
  • Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis.
  • Proficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods.
  • Strong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies.
  • Experience with automated assembly systems, robotics, or high-volume manufacturing.
  • Knowledge of polymer processing, metal fabrication, laser welding or additive manufacturing.
  • Experience in Audit Readiness and Internal/External Audits with the various Regulatory bodies (FDA, TGA, PMDA, etc.)
  • Ability to communicate within the discipline and with others who are not technically trained
  • Ability to prioritize tasks in a fast-paced environment.

The salary range for this position is between $120k - $135k per year depending on experience and location.

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About Atrium Medical

Atrium Medical is a medical device company that develops and manufactures products for cardiovascular, surgical, and other medical applications. The company's products include vascular grafts, endovascular stent grafts, and other devices used in cardiac and thoracic surgery. Atrium Medical was founded in 1981 and has been a subsidiary of Getinge AB since 2011.
Learn more about Atrium Medical
Size
500 employees
Industry
Healthcare
Founded
1904
* Ladders Estimates

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