Senior Principal Development Engineer

The Senior Principal Development Engineer will work in a dynamic organization in the Engineering group for R&DNorth America. This role has the responsibility for supporting and implementing projects related to Curium'sbusiness strategy in the space of new drug products and medical devices. The Senior Principal DevelopmentEngineer will be responsible for working in collaboration with project engineering, quality assurance, qualitycontrol, validation, and manufacturing through all phases of projects from concept evaluation through commercialproduct launch. Projects can include technical transfer, drug package development, design, scoping and estimation, integration, etc.

• Scale-up and transfer of new products to operations or contract manufacturers with a focus on Design Control.
• Participation and functional leadership in large cross-functional projects and project teams through process evaluation, design, and implementation of robust processes.
• Technical evaluation of new products relative to current site processes; process design for new products within existing or new manufacturing equipment.
• Experience leading investigations and preparing documents related to Customer Complaints for out of specification components and products.
• Provide manufacturing expertise and guidance of evaluation and design of new processes and equipment.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• PhD, Master's Degree, or Bachelor Degree in Mechanical Engineering or related field required.
• Fifteen or more years of relevant pharmaceutical or medical device experience required.
• Experience working in, or with, manufacturing operations as it pertains to development and life-cyclemanagement.
• Technical understanding of the medical device development process from concept to launch, including use ofDesign Control methodology, with knowledge of current industry practices and technologies.
• Experience with a risk-based approach to critical decisions during development.
• Knowledge of regulatory requirements, and validation activities needed for manufacturing pharmaceuticaland/or medical device products.
• Demonstrated experience in optimization of existing processes (life-cycle management).
• Proven experience within complex multi-discipline project teams in a highly regulated environment.
• Strong project management and organizational skills, including ability to lead a team, work independently, andas a team member.
• Strong oral and written communication skills with proven ability to communicate effectively in high pressureenvironments.
• Ability to react to problems and lead the team to develop solutions while communicating effectively to projectleadership and stakeholders.
• Experience leading formal Root Cause Analysis and problem-solving methodologies.
• Proficient with Microsoft Office (Excel, PowerPoint, SharePoint, Word), experience with MS Project and Visiopreferred.
• Demonstrated ability to perform data analysis to support experimental results.
• Six Sigma certification preferred, with experience using Minitab, or other statistical software.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.