Senior R&D Engineer-Sustaining

A bachelor’s degree in STEM (Science, Technology, Engineering, Math), and four (4) years of engineering experience within the medical device or equivalent regulated industry.
Or a master’s degree in STEM and two (2) years of engineering experience within the medical device or equivalent regulated industry.
Ability to make and present engineering decisions.
Ability to systematically manage multiple projects from initiation through closing phases.
Specific specialized engineering skills such as: Create & critique engineering cost analysis, Basic tooling design and drafting knowledge, Analyze and optimize existing processes and ability to create new processes, Create, analyze, and optimize manufacturing and quality systems, Basic product, design & prototyping.
Ability to train, create and critique training; Strong interpersonal skills.
Ability to apply comparative statistics.
Software application skills.
Problem solving ability.
Ability to create, review and coordinate test protocols and reports.
Ability to generate engineering proposals.
Oral and written presentation skills.
Ability to lead multi-functional teams.
Demonstrated ability to create and implement project plans.
Ability to create and control a budget.

Lead multi-functional design control activities.
Consultant/Department expert with technical expertise and business knowledge.
Organizational credibility and knowledge.
Guides and directs others within the Department while being results oriented and a project Leader.
Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
Participates and/or leads multi-functional teams.
Provides technical support on components, material methods, systems, and equipment.
Develops physical and functional test requirements to assure specifications & regulations are met.
Writes and approves protocols, reports, and data.
Oversees testing outlined in protocols and test methods.
Coordinates/develops validation studies on equipment & processes.
Drives design controls and analyzes design inputs.
Conducts complaint(s) investigations.
Understands and follows company procedures and regulatory requirements.
Prepares and submits approval requests for project funding. Participates in project planning, budgeting, scheduling, and tracking.
Plans and coordinates engineering test builds.
Analyzes problems in design, process, and test development. Recommend solutions.
Prepares and presents oral and written project updates and technical discussions.
Mentors and provides technical guidance to junior engineers and team members.

Strong interpersonal and influencing skills.
Excellent technical judgment.
Effective communication skills.
Material Science.
Bioengineering principles.
Demonstrated accountability for successful completion of designated tasks.
Team-oriented.
Understanding of disciplined product development processes and quality requirements.
Strong fit with BD values.
Demonstrated ability to use statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment. Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred.
Design of Experiments (DOE), statistical methods.
Knowledge of regulatory and quality requirements (21CFR820.30).
Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions.
Experience with clinical studies, human physiology, and simulated product use studies.
Experience with contact and non-contact metrology.
Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.
Experience with manufacturing process validation including strategy development, First Article Inspection, and Factory Acceptance Testing.