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BD · 3 weeks ago

Sr. Engineer (Hybrid - Brea, CA)

USA CA – Brea

Full-time

Hybrid

Mid, Senior Level

$102K/yr - $168K/yr

6+ years exp

BD is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The Sr. Engineer will be responsible for developing and implementing new products through established design control processes and will engage in activities such as technical drawing creation, design verification, and functional testing.

Health CareMedical DeviceTechnical Support

Comp. & Benefits

No H1B

Responsibilities

Demonstrates proficiency in creating technical drawings, developing design verification strategies, conducting functional device testing, performing testing by analysis, technical writing (protocols, reports, work instructions), and applying engineering principles for design and analysis, including statistical analysis and sample plan development

Identifies external technologies and their critical strengths/weaknesses, nurtures Invention Disclosure Records (IDRs) from early stages, and contributes to the organization's intellectual property portfolio through creative problem-solving and innovative approaches

Actively participates in external activities that enhance BD's brand recognition, including writing technical papers and generating intellectual property (IP), while staying current with industry developments and expanding professional knowledge

Demonstrates accountability for timely achievement of goals, assesses project needs, mitigates risks, supports Business Development Goals (BDGs), represents BD on standards committees, and communicates effectively with cross-functional partners while resolving team conflicts

Exhibits strong interpersonal influence and persuasion skills with situational awareness, promotes an inclusive work environment that leverages diversity, demonstrates decisiveness despite ambiguity, and autonomously drives projects and deliverables with minimal supervision

Qualification

Mechanical EngineeringBiomedical EngineeringDesign ControlsStatistical AnalysisQuality System RequirementsPrototypingTechnical WritingInterpersonal SkillsProblem SolvingTeam Collaboration

Required

Bachelor's Degree in Mechanical or Biomedical Engineering with 6+ years of experience in medical device or other regulated industry, OR an Advanced Degree in Mechanical or Biomedical Engineering

Demonstrated track record of technical problem solving, effective product development, proficiency in solid mechanics/mechanics of materials, and statistical methods/tools

Design controls expertise for medical or regulated industry, with knowledge of regulatory standards including FDA QSR 21 CFR 820, ISO 13845, ISO14971, ISO 80369, and related collateral standards

Familiarity with both traditional and modern fabrication techniques applicable to medical device production

Comprehensive understanding of quality system requirements and design control processes specific to medical device development and manufacturing