R&D Engineer

Katalyst CRO; Dexter (MI); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO in Dexter, Michigan, seeks an integration-focused engineer to lead cross-functional workstreams across design controls and quality systems for medical device platforms. You will drive interface definitions, requirements alignment, and regulatory-compliant DHF activities, collaborating with engineering, quality, and regulatory teams.

The role emphasizes V&V planning, test method development, and proactive risk mitigation in a highly collaborative environment.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Materials Science or related field.
• Advanced degree preferred for senior level roles.
• Strong experience in medical device development within a design controls environment.

Responsibilities

• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision-making across assigned deliverables with engineering leadership.
• Own and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.
• Support risk management documentation and mitigation strategy activities.
• Lead verification and validation planning and execution activities.
• Support DHF development and maintenance in regulatory compliance.
• Lead or oversee test method development and validation activities for integration readiness.
• Conduct feasibility studies, prototype development, and iterative testing across device platforms.
• Perform root cause analysis and mitigate integration risks.
• Collaborate with quality, manufacturing, supplier engineering, and regulatory teams to drive execution.

Skills

Technical leadership

Cross-functional collaboration

Communication

Problem solving

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering or Materials Science

Advanced degree preferred

Tools

Windchill

PLM/quality systems

V&V tools

Job description

• The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.
• This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision-making across assigned deliverables in collaboration with engineering leadership.
• Own and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.
• Support risk management documentation and mitigation strategy activities.
• Lead verification & validation (V&V) planning and execution activities.
• Support DHF development and maintenance in compliance with regulatory standards.
• Lead or oversee test method development and validation activities to ensure integration readiness.
• Conduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.
• Perform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.
• Partner cross-functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.
• Influence cross-functional stakeholders and provide technical leadership without direct line management responsibility.
• Collaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.

Job Description

• The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.
• This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision-making across assigned deliverables in collaboration with engineering leadership.
• Own and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.
• Support risk management documentation and mitigation strategy activities.
• Lead verification & validation (V&V) planning and execution activities.
• Support DHF development and maintenance in compliance with regulatory standards.
• Lead or oversee test method development and validation activities to ensure integration readiness.
• Conduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.
• Perform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.
• Partner cross-functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.
• Influence cross-functional stakeholders and provide technical leadership without direct line management responsibility.
• Collaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.

Roles & Responsibilities

• The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.
• This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision-making across assigned deliverables in collaboration with engineering leadership.
• Own and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.
• Support risk management documentation and mitigation strategy activities.
• Lead verification & validation (V&V) planning and execution activities.
• Support DHF development and maintenance in compliance with regulatory standards.
• Lead or oversee test method development and validation activities to ensure integration readiness.Conduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.
• Perform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.
• Partner cross-functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.
• Influence cross-functional stakeholders and provide technical leadership without direct line management responsibility.
• Collaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field. Advanced degree preferred.
• 6+ years of industry experience or 4+ years with an advanced degree.
• Strong experience in medical device development within a design controls environment.
• Experience with catheter-based and/or single-use medical devices.
• Proven ability to lead technical workstreams and influence cross-functional teams.
• Strong working knowledge of design controls, DHF documentation, risk management, V&V, traceability, and change control.
• Ability to work independently with minimal guidance.
• Strong problem-solving, communication, and stakeholder management skills.
• Experience with Windchill or similar PLM/quality systems preferred.
• Experience with DMR deliverables including prints, specification maps, and BOM creation preferred.
• Experience with test method development and validation preferred.
• Background in balloon catheter or catheter-based systems preferred.
• Familiarity with Class II/III medical device regulations and quality systems preferred.
• Experience with product or technology integration activities preferred.
• Self-starter with strong accountability, adaptability, and ability to operate in ambiguity.