Design Services Principal Engineer in North Attleboro, Massachusetts at Theragenics Corp

Principal Research and Development Engineer — Design Services

Executive Summary

The Principal Research and Development Engineer is a senior technical and hands-on role responsible for solving complex engineering problems and creating advanced research, modeling, validation, and testing capabilities for contracted medical-device product development programs. This individual combines strong engineering fundamentals with demonstrated success in an academic or industrial research, validation, or testing environment. The role leads the development of physics-based models, experimental methods, custom test systems, measurement strategies, and technically defensible conclusions from early feasibility through formal verification and validation. The position requires the ability to communicate directly with customers at a high technical level, lead multidisciplinary engineering efforts, mentor engineers and technicians, and manage the operation and growth of a medical-device testing laboratory. An advanced degree is preferred, but demonstrated technical depth and relevant accomplishments are more important than a specific degree credential.

KEY RESPONSABILITIES

• Provide principal-level technical leadership for advanced engineering research, analytical and computational modeling, experimental development, and complex medical-device testing.
• Translate ambiguous customer, clinical, product, and verification needs into clear technical questions, measurable requirements, research plans, models, experiments, test methods, and decision criteria.
• Develop and apply analytical and numerical models, including finite element analysis, computational fluid dynamics, tolerance and sensitivity analyses, reliability models, and other physics-based methods appropriate to the problem.
• Establish model credibility by defining intended use, assumptions, boundary conditions, verification, calibration, validation or correlation, sensitivity, uncertainty, and limitations.
• Architect and develop custom test systems integrating mechanical fixtures, sensors, actuators, motion control, pneumatics, hydraulics, thermal systems, optics, electronics, controls, software, and synchronized data acquisition as required.
• Lead test-method development and qualification, including assessment of accuracy, precision, linearity, range, robustness, repeatability, reproducibility, measurement uncertainty, and method suitability.
• Create risk-based verification and validation strategies addressing requirements traceability, worst-case selection, product configurations, sample rationale, fixtures, simulated-use conditions, data integrity, acceptance criteria, and reporting.
• Apply experimental design and statistical methods to screening, optimization, equivalence, tolerance, reliability, durability, and root-cause investigations; distinguish statistical significance from engineering and clinical significance.
• Lead multidisciplinary technical problem solving for mechanical, fluidic, electrical, software, material, measurement, and human-interface issues using mechanism-based analysis and targeted experimentation.
• Author and approve research plans, calculations, protocols, engineering reports, test reports, technical memos, specifications, design-review packages, and other records required by the quality system and customer program.
• Interface directly with customers to clarify technical needs, present findings, explain assumptions and limitations, lead design and test-readiness reviews, resolve technical disagreement, and recommend practical options and trade-offs.
• Provide technical leadership across contracted product-development programs, including scope definition, estimate support, technical risk management, milestone planning, decision documentation, and recovery planning.
• Manage daily operation and strategic development of the testing laboratory, including workflow, scheduling, access, training, safety, preventive maintenance, calibration, environmental controls, consumables, data systems, and audit readiness.
• Identify laboratory capability gaps and lead capital expenditure projects from user requirements and business justification through vendor selection, facility planning, approval, purchase, FAT/SAT, installation, qualification, training, and benefit realization.
• Supervise and develop laboratory technicians and engineers through clear assignments, qualification plans, technical review, coaching, cross-training, performance feedback, and succession planning.
• Ensure laboratory and test-system safety through risk assessments, safe operating procedures, interlocks, emergency provisions, management of change, and stop-work authority for electrical, pressure, motion, thermal, laser, chemical, biological, and stored-energy hazards.
• Advance reusable organizational capability through standard methods, modular test platforms, automation, validated analysis tools, templates, technical communities of practice, invention disclosures, and protection of intellectual property and trade secrets.
• Continuously improve engineering quality, cycle time, laboratory utilization, data integrity, technical documentation, and cross-functional collaboration.

QUALIFICATIONS

1. Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, Aerospace Engineering, or a closely related technical field required; advanced degree such as an MS or PhD preferred.
2. Demonstrated advanced competency in an academic or industrial research, engineering analysis, validation, or testing environment. Degree level alone does not substitute for evidence of technical accomplishment and independent judgment.
3. Typically 10+ years of relevant engineering experience, although candidates with fewer years may be considered when they demonstrate exceptional research depth, test-system leadership, and principal-level impact.
4. Demonstrated ability to formulate and solve complex, poorly defined engineering problems using first principles, modeling, experimentation, statistics, and sound engineering judgment.
5. Experience developing custom test equipment, fixtures, measurement systems, data acquisition, controls, and analysis methods for complex medical devices or comparable regulated products.
6. Experience with formal verification and validation, test-method development and qualification, requirements traceability, risk management, and technically defensible reporting.
7. Working knowledge of medical-device design controls and quality-system expectations, including ISO 13485, ISO 14971, and applicable FDA Quality Management System requirements.
8. Ability to communicate complex concepts clearly to customer scientists, engineers, quality and regulatory personnel, program leaders, and executives.
9. Ability to lead multidisciplinary engineering teams, work independently with limited supervision, and mentor engineers and technicians.
10. Experience managing laboratory operations, equipment readiness, safety, calibration, training, capacity, and technical resources preferred.
11. Experience developing and executing capital equipment requests, vendor evaluations, equipment acceptance, installation, and qualification preferred.