As a Principal Project Engineer, you will be responsible for leading highly complex projects to introduce and optimize best-in-class, fully automated manufacturing lines within Abbott’s Third-Party Manufacturers. You will manage the entire lifecycle of new equipment and major modifications to existing footprints from design review through to production ramp‑up.
Key Responsibilities
Manage, plan, and implement major engineering projects associated with assembly of finished product including new product development, build, test, commissioning, validation activities (IQ/OQ/PQ), RCE documentation etc. as required.
Drive activities at the equipment supplier(s) to ensure that production start‑up through to scale up to increased volumes are achieved per ADC requirements.
Provide technical leadership and project management for a team.
Lead and participate in design, planning, introduction, and sustaining of automated manufacturing lines.
Ensure the project meets quality requirements of all key internal stakeholders including but not limited to internal (ADC) R&D, Regulatory, Quality groups while also being the key contact for site operations to ensure adherence to the required ADC policies and procedures. Measure and report progress against approved timelines.
Ensure prompt attention of Senior Management in areas of risk, which might have an adverse effect on project delivery, product and/or safety.
Act as an effective project leader in supporting timelines, quality disciplines, decisions, and practices.
Interface with product team members, department managers, designers/equipment manufacturers, R&D, Quality, and Regulatory personnel.
Represent department/division on projects.
Show initiative in developing and promoting implementation of innovative ideas or potential solutions and champion change without prompting. Control and implement any relevant engineering changes.
Independently conceive and develop problem‑solving approaches that require application of advanced technical knowledge.
Independently design and lead complex engineering studies and experiments often with multiple variables. Analyze complex problems and identify their impact using statistical analysis of measurement results. Set complex design and process requirements.
Responsible for completing documentation in a timely manner and in accordance with business standards.
Initial project related travel is to be expected – approximately 25% to Europe and US (primarily).
Skills
Capability of creating process documentation and technical procedures associated with medical device processes & equipment.
Capability of reviewing equipment design and conferring with scientific, engineering, and technical personnel to select suitable measurement methods and resolve hardware and software problems (such as product or system malfunctions, incomplete test data, data interpretation or coding issues).
Analytical skills required to perform root cause analysis, develop and coordinate corrective action measures, and define monitoring improvements for issues affecting yield and cycle time problems.
Capable of analysing and interpreting process characterization data and preparing technical reports for use by engineering and management personnel.
Strong interpersonal skills for liaising between vendors, suppliers, Third Party Manufacturers, host‑site personnel, management, and colleagues.
Qualifications and Experience
Relevant Level 8 Degree in Engineering/Manufacturing, Science discipline, and equivalent with 5+ years progressive technical experience and demonstrated competence. Automation / Electronics / Mechatronics degree preferred.
Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Strong organizational and follow‑up skills, as well as attention to detail.
Immediate reporting line will be to off‑site remote manager, with on‑site team‑based support. The individual will be required to be self‑starting and self‑motivated.
Proven track‑record of accomplishment in applying continuous improvement projects.
Preferred
Minimum 5 years of relevant experience with automated manufacturing processes preferred.
2+ years previous experience in a Medical Device or Pharmaceutical environment preferred.
Experience of project managing the implementation of high‑speed automation lines in a high‑volume medical device environment and new product process development preferred.
Experience of design, commissioning, and validation lifecycles of complex automated equipment preferred.
Knowledge and competence in development, validation, and launch of high‑volume manufacturing lines for medical devices.
Prior experience and familiarity with a cGMP, FDA, and ISO regulated environment.
Understanding & knowledge of automated manufacturing systems, measuring technology, equipment software, pneumatics, electronics, vision systems, lasers, and GAMP guidelines.
Important Information
Any offer of employment is conditional upon the successful completion of a pre‑employment medical examination, including drug and alcohol screening, conducted by a Company‑designated medical practitioner.
Abbott is an equal opportunities employer.
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