Auto req 10718BR
Job Posting Title Sr Mgr Engineering - Device Engineering
Career Category Operations
Employee Subgroup Salaried FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description Senior Manager is responsible for providing technical leadership to a group of engineers responsible for device development from pre-commercial through commercial support of parenteral biological products. The intended focus will be to manage a team to sustain and improve devices currently on the market. The Senior Manager is responsible to meet key performance metrics, supervise and technically develop direct reports and ensures schedules are completed on time. Also, to ensure Project Teams utilize the Device Commercialization Business Process and Design Controls during the development. Scope will include a wide range of products including; needle protection systems, autoinjectors, and reconstitution systems.
Responsibilities
-Oversight and execution of drug delivery projects.
- Sustaining support for commercialized drug delivery projects.
-Global oversight responsibilities of device related project at Amgen sites.
-Responsible for engineering aspects of the development and commercialization of drug delivery devices
-Work cross-functionally with individuals and project teams in Marketing, Operations, and Development and serve as a primary contact with Amgen's external drug delivery partners.
-Work with Amgens partners in the support of device, diagnostics, and ancillary items.
Basic Qualifications - Doctorate degree & 2 years of directly related experience
OR
- Masters degree & 6 years of directly related experience
OR
- Bachelors degree & 8 years of directly related experience
OR
- Associates degree & 10 years of directly related experience
OR
- High school diploma / GED & 12 years of directly related experience
AND
- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications MS degree in Mechanical Engineering, or Electrical Engineering or other Engineering/Life Sciences
12 years of experience in engineering specific to the medical device or biotech/pharmaceutical industry. Including 7 years in a management/supervisory role.
-Strong background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired.
-Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
-Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
-Familiar with the following standards:
US Good Manufacturing Practices 21CFR820
Quality Management ISO 13485
Risk Management ISO 14971
EU Medical Device requirements Council Directive 93/42/EEC
Medical Electrical Equipment EN 60601
Demonstrated Competencies/Skills:
1) Leadership role in projects and functional areas
2) Independent thinker with demonstrated skills working in teams or leading project teams
3) Strong Interpersonal and communication skills
