Principal Mechanical Engineer

Principal Mechanical Engineer

Mallinckrodt Pharmaceuticals

Dublin, Ireland

Job Description

The principle mechanical engineer will represent the device engineering group on cross functional project teams, having responsibility to lead and/or participate in the design and development activities of medical devices and combination products through the lifecycle to commercial product. Activities will include identifying, articulating, and quantifying Design input requirements; translating these requirements into product requirements and specifications; assessing the suitability of current designs and technologies to meet these requirements; and, where necessary, developing and implementing design solutions to address needs or gaps with external partners and CMOs, especially with design authorities for platform delivery devices.

Job Responsibilities

  • Demonstrates a high level of professionalism with key stakeholders; reports to senior management on critical device related issues; drives collaborative development with external partners to ensure technical requirements are achieved;
  • Develop an understanding of customer needs and processes to ensure relevant and innovative product development solutions;
  • Be SME for the development of device elements of combination products and champion device iterations. Development and qualifications with internal and external stakeholders, including regulatory agencies;
  • Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks;
  • Application of Design for Manufacturing/Assembly (DFM);
  • Define and review tolerance stack-up analysis for complex mechanical assemblies;
  • Drive root cause investigations related to mechanical anomalies in device performance;
  • Provide guidance for FEA analysis and in interpreting results;
  • Lead development of appropriate test plans to fully characterize devices under development, in particular platform devices from external partners. Report on and drive review on these characterizations as inputs to key design readiness decisions;
  • Conduct design reviews, FMEA's and design verification programs;
  • Prepare technical files and update documents including product specifications, DHF, drawings, bill of materials, study protocols and supporting design verification activities;
  • Manage and assess external vendors/supplier work and capabilities;
  • Support design validation and process validation programs and lead reviews of any anomalies related to mechanical performance;
  • Maintain/update DHF with mechanical design deliverables and lead device design transfer and manage post approval device changes;
  • Define control strategy for the finished product;
  • Contribute to a culture of innovation by proactively generating novel solutions to improve product performance or enhance products' ability to address customer needs;
  • Support regulatory submissions and approvals for combination product programs;
  • Support post approval regulatory submission for market expansion and timely technical responses to FDA and healthcare authority inquiries;
  • Lead technical aspects of product design change to support quality closures, engaging with medical affairs, supply chain, quality, regulatory, packaging and R&D teams to gather and incorporate inputs for managing marketed product changes;
  • Collaborate with R&D, supply chain, and commercial team to develop drug delivery devices for pipeline products and to provide post launch market support globally;
  • Expected to work on a regular basis with groups in different geographical region, e.g., early and late conference calls Travel estimated at 10% of time, including some global travel.

Job Requirements

  • Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Engineering Technology or other relevant Degree;
  • > 8 years’ experience in the development and registration (up to commercialization) of drug delivery devices and medical devices, ideally with in-depth technical knowledge of injectable drug delivery systems;
  • Works well with other engineers in a collaborative, fast-paced goal-driven environment;
  • Experience of working with GMP, international device regulations and design controls, with practical understanding of key topics: risk management, sterilization, usability;
  • Understanding of product development considerations for tightly controlled, high-volume manufacturing processes;
  • Experienced driving the design of plastic components and sub-assemblies for high volume manufacturing methods – account for DfX;
  • Strong Computer skills (MS Word, Excel, PowerPoint, Outlook, Internet);
  • Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues;
  • Communicates up and down appropriately and effectively; adjusts to fit the audience and the message; strongly gets a message across;
  • Excellent at collaboration - ability to develop professional relationship and collaborate with team members, stakeholders and external partners.

Preferred:

  • Thorough and proven knowledge Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment;
  • Strong materials background, particularly in plastics and manufacturing of plastic components;
  • Outgoing personality with a strong desire to provide mentorship within the organization;
  • Is a self-starter, can manage multiple tasks, and work with minimal supervision;
  • Extensive experience with Solidworks or other CAD software;
  • Experience in a technical role on a cross-functional team, leadership role preferred;
  • Demonstrated experience in project management;
  • Knowledge of designing and executing user studies in support of product requirement specification development.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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